Recent:
- 12/16/2008: Revised Debarment List - Kindness added.
- 12/16/2008: Revised Debarment List - Page added.
- 11/10/2008: Added clinical investigator to restrictions list (Raval).
- 10/24/2008: Added clinical investigator to disqualification list (Garjian).
- 09/29/2008: Chapter 10 of Regulatory Procedures
Manual (RPM) was updated as detailed below.
- Chapter 10 - Other Procedures
- Section 10-8 Ad Hoc Committee, 10-8-5 Procedures - Revised to add a paragraph to describe requirements for requests for an appeal ad hoc committee.
- Section 10-10 Expert Support for Cases:
- 10-10-1 Purpose – Revised to add "or other specialized" support to the terms used to describe the types of expert support that may be needed for a case.
- 10-10-2 Responsibility – Revised to further describe the role of centers in assuring FDA has expert support for a case.
- 10-10-3 Criteria for Determining the Level of Expert Support - Revised to add "unprecedented issues" to the types of cases that should generally prompt centers to consider obtaining concurrence from experts.
- 9/22/2008: Revised Debarment List - Corrected spelling for "Rodriguez, Juan Manuel."
- 9/22/2008: Revised Debarment List - added Campbell.
- 9/9/2008: Removed "CDER" as Center to disqualify. Disqualification
resulted from criminal investigation.
- 9/2/2008: Added clinical investigator to disqualification list ( Holland ).
- 8/22/2008: Added clinical investigator to disqualification list
(Guy).
- 8/6/2008: Added clinical investigator to disqualification list (Gentry).
- 07/22/2008: Published Draft CPG
Sec. 540.370, Fish and Fishery Products -- Decomposition. Withdrawal
Notice of Docket No. 2008-D-0265 CPG 540.575 Fish--Fresh and Frozen--Adulteration
Involving Decomposition (CPG 7108.05)
- 07/21/2008: Chapter 4 of Regulatory Procedures
Manual (RPM) was updated as detailed below.
- Chapter 4 - Advisory Actions
- Exhibit 4-1 – Procedures for Clearing FDA Warning Letters and Untitled Letters, Section 6.4.1 Model Letters and Audit Schedules
Revised to add center concurrence “Tissue Residues Warning Letter for
Producers who Medicate Animals” to the audit program.
- 7/17/2008: Added clinical investigator to restricted list for clinical
investigator (Fabre).
- 6/2/2008: Updated CBER Action Dates for Drs. Lieberman, Roberts, Slanzinski,
and Tewari.
- 06/23/2008: Chapter 4 of Regulatory Procedures
Manual (RPM) was updated
as detailed below.
- Chapter 4 - Advisory Actions
- 4-1-10 Warning Letter Format
Paragraph 13 – Revised to remove the words "issues
and" in the sentence reading: "The issues and
violations cited in this letter…"
- Exhibit 4-1 –Procedures for Clearing FDA Warning
Letters and Untitled Letters
Revised
to reflect the use of the Compliance Management System (CMS or
MARCS-CMS). This application replaces the AIMS Violation Letter
Tracking System (VLTS).
- 6/2/2008: Added clinical investigator to disqualification list (Kirkman Campbell).
- Change
to Compliance Program Guidance Manual; Added new CP 7386.003a,
"Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray
Equipment"
- 5/15/2008: Added clinical investigator to disqualification list (Vestal).
- 05/06/2008: Added clinical investigator to disqualification list
(Lofgren).
- 04/28/2008: Added clinical investigator to disqualification list (Achreja)
- 04/18/2008: Removed clinical investigator from restricted list.
- 03/21/2008: Added clinical investigator to disqualification list.
- 03/19/2008:
Change to Compliance Program Guidance Manual; Added new CP 7342.007,
"Imported CBER-Regulated Products" and 7342.007 Addendum, "Imported
Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps)"
- 03/11/2008: 1) Updated contact on GLP Question & Answer 2) Added two clinical investigators to disqualification list.
- 03/05/2008:
March 2008 edition of the Regulatory Procedures
Manual (RPM) published;
Chapters 1, 2, 4, 5, 6, 7, 8, 9, and 10 updated, as detailed below.
- Chapter 1 - Regulatory Organization
- Updated to reflect changes in organizational structure and
phone numbers.
- Chapter 2 - FDA Authority
- 2-2 Selected Amendments to the Federal Food, Drug, and Cosmetic
Act - Added summary of the "Dietary Supplement
and Nonprescription Drug Consumer Protection Act of 2006."
- Chapter 4 - Advisory Actions
- 4-1-4 Center Concurrence and Letters Issued By Centers, paragraph
2. (CDER) - Replaced "Team Biologics (Core Team)" with "drug
experience" reporting to correct terminology.
- 4-1-5 Letters for Illegal Promotional Activities -
Removed the instruction NOT to use Untitled Letters if a center
would not support regulatory action.
- 4-1-6 Multiple Center Review, paragraph 2 -
Clarified that recommendations requiring review by more than
one center should be reviewed by the centers concurrently, not sequentially.
- 4-1-10 Warning Letter Format
- paragraph 8 - Modified to reference new paragraph 13.
- paragraph 13 - Added standardized language for the closing
paragraphs of drug Warning Letters.
- 4-1-14 Center for Biologics Evaluation and Research (CBER),
paragraph 4. Warning Letter Recommendations, b.
For Biological Drugs and Devices: - Added instruction that
Warning Letter recommendations for therapeutic Biological Drugs are sent
to CDER for concurrence.
- 4-1-15 Center for Drug Evaluation And Research (CDER),
- paragraph 2. Surveillance Inspections For Assessing Conformance
With Adulteration Provisions of the Act, Including GMP -
Replaced the reference to "Team Biologics" with "appropriately
trained investigators, preferably Level III certified drug
investigators..."
- paragraph 3. Standard CDER Charges -
Added "j. Adverse Drug Experience Reporting Violations and NDA
Field Alert Reporting Violations" to provide language for
section 505(k)(1) violations.
- Chapter 5 - Administrative Actions
- 5-5-2 Detention of Devices, paragraph 3. Detention Policy -
Added statements regarding Administrative Detention of Devices,
previously in "6-1-2 - General Guidelines For Seizures, 3. Voluntary
Hold Or Embargo."
- 5-6-5 (License) Revocation Procedures -
Added reference to the WL procedures in Chapter 4, Ex. 4-1.
- 5-6-7 (License) Suspension Procedures -
Added a reference to the WL procedures in Ex. 4-1.
- Updated IOM References throughout.
- Chapter 6 - Judicial Actions
- 6-1-2 General Guidelines For Seizure, paragraph 3. Voluntary
Hold Or Embargo - Updated to add a reference to provisions
for the Administrative Detention of Food.
- 6-1-11 Disposition of Seized Articles, paragraph 5. Reconditioning
Operations, c. Denaturing - Updated IOM reference.
- 6-1-12 Costs Of Supervision - Clarified
by using the term "disposal" rather than "conversion."
- Exhibit 6-28, Rule 44. Proving an Official Record -
Updated.
- Exhibit 6-29, Rule 6. The Grand Jury -
Updated.
- Chapter 7 - Recall Procedures
- 7-5-1 Firm Initiated Recalls, Paragraph 1. Recall Alert -
Replaced the phrase "blood product recalls" with "biologics recalls" because
24 hour Alerts are not required for any biological product recalls for which
CBER has issued an "alert to possible recall" to the field.
- Attachment B - Recommendation for Recall Classification,
Item 1. Product Description (INT), Trade Name..., paragraph "a. For
each product, provide as applicable:" - Deleted
the instruction "For biological recalls obtain the recalling firm's License/Registration
number. These items are to be inserted on the appropriate Center
specific pages." because this information is not required in
the RES system, and, therefore, no longer needs to be collected.
- "International Relations Staff" was changed to "Office of
International Programs" throughout the chapter.
- Chapter 8 - Emergency Procedures
- Updated IOM references throughout.
- Chapter 9 - Import Operations and Actions
- Includes recent editorial revisions, as detailed in the 02/19/2008 entry
to the Revisions and Update List.
- Chapter 10 - Other Procedures
- 10-1 Communications - District and Center Responsibilities -
Added.
- 10-4 Inspection of Food Records - Sections 414(a) and 704(a) -
Added.
- 02/25/2008: 1) Revised list to add a clinical investigator to Disqualified/Totally
Restricted List for Clinical Investigators.
- 02/19/2008:
The Regulatory
Procedures Manual (RPM) has been revised:
- Chapter 9 (Rev. 2002) is currently under revision. The editorial
revisions detailed below were made by DIOP in January 2008:
- Subchapter 9-1, Import Procedures, Subchapter
- Entries, Entry Processing, paragraph four (4) -
Added instructional note to districts: "Note:
As of this update additional "Other Government Agency" (OGA)
flags have been added. If necessary, further guidance on OGA
flags can be obtained by contacting the Division of Import
Operations and Policy (DIOP) HFC-170." (To reflect
changes to the FD Flags as a result of the BTA Amendments to
the FFD&CA.)
- Subchapter 9-1, Import Procedures,
Subchapter – Entries,
Formal Entries, paragraph one (1) - The following
statement "All articles
offered for import into the U.S. (entries) that have a value
greater than $1200 (current) are considered by CBP to be
formal entries." CHANGED
TO "All articles offered for import into the U.S.
(entries) that have a value greater than $2000 (current) are
considered by CBP to be formal entries." (To reflect
CBP's change in the dollar
value limit for informal entries from $1200 to $2000.)
- Subchapter 9-1, Import Procedures,
Subchapter – Entries,
Informal Entries, paragraph one (1) - The following
statement "Under current
CBP procedures, entries with a value less than $1200 do not
require posting a redelivery bond." CHANGED TO "Under
current CBP procedures, entries with a value less than $2000
do not require posting a redelivery bond." (To reflect
CBP's change in the dollar
value limit for informal entries from $1200 to $2000.)
- Subchapter 9-3 - Removed and replaced with the statement: "RPM
Subchapter 9-3, Importation of Biological Products was removed in January,
2008 per CBER request. For guidance regarding the importation of biological
products, Districts should contact DIOP (HFC-170)." (To
reflect Center requested removal of this subchapter.)
- Subchapter 9-6, Detention without Physical
Examination, Direct Reference Authority Recommendations,
paragraph one (1) - "....are assumed
to have CFSAN or CDRH concurrence" CHANGED TO "....are
assumed to have appropriate Center concurrence..."
(To reflect direct reference authorities from any Center.)
- Subchapter 9-6, Detention without Physical
Examination, Direct Reference Authority Recommendations,
paragraph one (1) - "....recommendations
for the automatic detention of latex condoms." CHANGED TO "....recommendations
for detention without physical examination for salmonella in
animal feed; and recommendations for detention without physical
examination of latex condoms." (To reflect current
terminology and add another example.)
- Subchapter 9-6, Removal from Detention
without Physical Examination, paragraph nine (9) - "....(Refer
to Laboratory Manual (LM), for guidance regarding private
laboratories.)" CHANGED TO "(Refer
to ORA Laboratory Manual (LM), Volume III, Section 7) for guidance
regarding private laboratories." (To reflect current
name/structure of the manual.)
- Subchapter 9-7, Notice of Detention
and Hearing, Custody of Detained Shipments, paragraph two
(2) - "Informal entries, those entries whose
value is currently less than $1200, are usually not imported
under bond." CHANGED
TO "Informal entries, those entries whose value
is currently less than $2000, are usually not imported under
bond." (To
reflect CBP's
change in the dollar value limit for informal entries from
$1200 to $2000.)
- Throughout Chapter 9 -
- All references to "Automatic Detention" CHANGED TO "Detention
Without Physical Examination" (To reflect current
terminology and agency policy.)
- CBP form numbers "CF" CHANGED TO "CBP." (To
reflect Customs and Border Protection's current and
proper name.)
- "Customs Service" CHANGED TO "2 Customs and Border Protection" or "CBP." (To
reflect Customs and Border Protection's current and
proper name.)
- All references to "LISTS" DELETED. (To
remove outdated reference.)
- All references to "when OASIS is operational" DELETED.
(To reflect the fact OASIS is operational in all Districts.)
- All references to OASIS functionality that are not accurate
were CHANGED TO reflect current OASIS processes. (To reflect
the fact OASIS is operational in all Districts.)
- Department of the Treasury CHANGED TO Department
of Homeland Security. (To reflect current status of
US Customs and Border Protection as a component agency of
DHS.)
- References to specific branches or offices within the
Center for Foods and Applied Nutrition (CFSAN) or the Division
of Field Science (DFS) DELETED since either the functions
of the specific office or branch were transferred to another
office or the specific office or branch is defunct.
- 02/15/2008:
http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm 1) Revised list to add a clinical investigator to Disqualified/Totally
Restricted List for Clinical Investigators and 2) Updated link to the
Office of Research Integrity, Administrative Actions.
2007:
- 11/08/2007:
In the Compliance Program Guidance
Manual list,
a new Medical Devices compliance program 7386.001 "Inspection
and Field Testing of Radiation-Emitting Electronic Products" supersedes
three withdrawn Programs:
- 7386.001 "Inspection of Manufacturers of Laser Products,"
- 7386.002 "Field Implementation of the Sunlamp and
Sunlamp Products Performance Standard As Amended,” and
- 7386.004 "Field Compliance Testing of Cabinet X-Ray
Equipment."
- 10/10/2007:
Revised list to remove 1 clinical investigator from restricted list and added to restrictions removed list.
- 09/14/2007:
Revised list to remove one firm from the Application Integrity Policy List.
- 08/1/2007:
Revised list to remove 1 clinical investigator from restricted list and added to restrictions removed list.
- 07/13/2007
CPG Manual Revised; "Sec. 130.300 FDA Access to Results
of Quality Assurance Program Audits and Inspections (CPG 7151.02)",
amended to incorporate the current references and cites to the Device
Quality System Regulation (21 CFR Part 820)
- 06/28/2007:
Contact information updated for a series of BIMO
pages.
- 06/01/2007:
Compliance
Program Guidance Manual, Program 7361.003 "OTC Drug Monograph
Implementation" is
now on-line in a revised version.
Program 7363.001 "Fraudulent Drugs" is reestablished
on-line.
Programs 7329.001 "Domestic Cosmetics Program" and 7329.002 "Imported
Cosmetics Program" are combined into revised program 7329.001 "Cosmetics
Program - Domestic and Imports"
- 04/27/2007:
In the Regulatory Procedures Manual March 2007, updated Chapter 4
(Advisory Actions) with revisions to Exhibit 4.1
- 04/16/2007:
Revised Debarment
List, 04/16/2007 - One person added.
- 03/28/2007:
March 2007 edition of the Regulatory
Procedures Manual (RPM) published; chapters 1, 4, 5, 6, 10 and
11 updated.
- 01/23/2007:
Revised list to add 1 new member, Restricted
List for Clinical Investigators
2006:
- 11/21/2006:
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated
November 21, 2006
- 11/09/2006:
Compliance Program Guidance
Manual, Program 7342.007 "Examination of Blood and Blood Components
Offered for Import" is withdrawn and replaced by Program 7342.007
"Imported Human Cells, Tissues, and Cellular and Tissue-based Products".
The withdrawn Program was never electronically available but the replacement
Program is now on-line.
- 11/02/2006:
CPG Manual Revised; "Sec. 100.550
Status and Responsibilities of Contract Sterilizers Engaged in the
Sterilization of Drugs and Devices (CPG 7150.16)", updated generally,
and specifically with respect to device registration regulations.
- 10/23/2006:
Revised list to add 1 new member, Disqualified/Totally
Restricted List for Clinical Investigators
- 10/17/2006:
Revised Debarment List, 10/17/2006
- One person added.
- 10/11/2006:
Revised list to add 1 new member, Disqualified/Totally
Restricted List for Clinical Investigators
- 08/24/2006:
New Guidance That Replaces CPG
Sec 110-300, Compliance Policy Guide Guidance for FDA Staff Registration
of Food Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
- 06/20/2006:
Compliance Program Guidance
Manual: Program 7371.001, "Animal Drug Manufacturing Inspections"
revised; program formerly titled "Drug Process and New Animal Drug
Inspections."
- 08/04/2006:
Clinical Investigator Agrees to Restrictions. See Restricted
List for Clinical Investigators for the details.
- 07/26/2006:
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990 Updated July 26,
2006
- 07/17/2006
Revised list to add 1 new member, Restricted
List for Clinical Investigators
- 06/20/2006
New Guidance which Replaces CPG
Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (CPG
7132c.02)
- 06/20/2006
DRAFT
COMPLIANCE POLICY GUIDE 160.900 Prescription Drug Marketing Act – Pedigree Requirements under 21 CFR Part 203
- 06/19/2006
March 2006 edition of the Regulatory
Procedures Manual (RPM) published.
- 06/15/2006:
Compliance Program Guidance Manual: Program 7382.845, "Inspection
of Medical Device Manufacturers " revised.
- 05/26/2006:
Draft Compliance
Policy Guide:
Guidance Levels for 3-MCPD (3- chloro-1,2-propanediol) in Acid-Hydrolyzed
Protein and Asian-Style Sauces
Revised list to add 1 new member, Restricted
List for Clinical Investigators
- 05/16/2006:
Revised Medical
Device Model Press Release
- 05/09/2006:
Revised list to change status
to Active - Exygen Research, State College, PA
- 04/07/2006:
Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated
April 7, 2006
- 03/08/2006:
Revised list to add 1 new member, Restricted
List for Clinical Investigators
- 02/09/2006:
Updated the program contact person (s) information on the following
pages:
http://www.fda.gov/ora/compliance_ref/bimo/default.htm
http://www.fda.gov/ora/compliance_ref/bimo/background.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
- 01/19/2006:
Change in classification (Class) - Pine
Acres Research Facility, Norton, MA
- 01/11/2006:
Updated list to remove restriction for 1 member. Restricted
List for Clinical Investigators
- 12/29/2005:
Revised Restricted
List for Clinical Investigators to add 1 new member
- 12/21/2005:
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990. Updated December
09, 2005
Edited list to correct typographical error in the initial of Dr. Farber
on Disqualified/Totally
Restricted List for Clinical Investigators
Updated "FDA AIP Contacts List" (December 2005) on the Application
Integrity Policy Information page
- 12/12/2005:
Revised CPG
Sec. 230.150 - Blood Donor Classification Statement, Paid or Volunteer
Donor
Revised CPG
Sec. 300.750 - Class III Devices Subject to 515(b) Requirements (CPG
7124.18)
Revoked CPG
Sec. 460.700 - Controlled Release Dosage Form Drugs - Rate of Release
of Active Ingredients (CPG 7132a.02)
- 12/06/2005:
Updated list to remove restriction for 1 member, 11/23/2005: Restricted
List for Clinical Investigators
- 12/01/2005:
Updated "FDA AIP Contacts List" (August 2005) on the Application
Integrity Policy Information page
- 11/29/2005:
Edited Compliance
Policy Guides Sec. 160.100 and 118 pages in Chapter
5 to reflect FDA organization and contact changes.
- 11/18/2005:
Added on-line link for
compliance program 7385.014, Mammography Facility Inspections.
Revised list to add 1 new member on Disqualified/Totally
Restricted List for Clinical Investigators
- 11/14/2005:
Revised list to add 1 new member, Disqualified/Totally
Restricted List for Clinical Investigators
- 11/10/2005:
Revised CPG Sec. 110.310 - Prior
Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
- 11/03/2005:
Revised list to remove one member from the Application
Integrity Policy List
- 10/31/2005:
Revised http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm to add one person and update the list contact person. Also, the contact
person was updated on:
http://www.fda.gov/ora/compliance_ref/bimo/asurlist.htm
http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm
- 09/15/2005:
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990 Updated September
15, 2005
- 09/13/2005:
Revised list to remove one member on the Application
Integrity Policy List
- 08/08/2005:
Revoked by Federal Register notice on 09/24/1998 (63 FR 51074), CPG
Sec. 615.100 Extra-Label
Use of New Animal Drugs in Food-Producing Animals (CPG 7125.06)
- 08/04/2005:
Updated the program contact person (s) information on the following
pages:
http://www.fda.gov/ora/compliance_ref/bimo/default.htm
http://www.fda.gov/ora/compliance_ref/bimo/background.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
http://www.fda.gov/ora/compliance_ref/bimo/comparison_chart/preface.html
http://www.fda.gov/ora/compliance_ref/bimo/glp/wh_list_intro.htm (and related GLP lists)
- 08/02/2005:
Table for Veterinary Medicine
compliance programs is updated to reflect on-line documents and/or
information now supplied by the Center for Veterinary Medicine.
- 07/28/2005:
Revised Debarment
List, 07/28/2005 - One person added.
- 07/18/2005:
Re-numbered existing biologics compliance program 7341.002 “Inspection
of Tissue Establishments” to 7341.002A and added new biologics compliance program 7341.002 “Inspection of Human Cells, Tissues, and Cellular and Tissue-based
Products (HCT/Ps).”
- 5/31/2005
Draft revised CPG Sec. 480-200 - Expiration Dating of Unit-Dose Repackaged
Drugs (CPG 7132b.11)
Notice of Availability (HTML)
(PDF)
Draft Guidance (MSWord)
(PDF)
- 05/20/2005:
Revised list to add 1 new member, Restricted
List for Clinical Investigators
- 05/19/2005:
Revised CPG Sec. 315.100 Illegal
Interstate Commercial Shipment of Dentures (CPG 7124.07)
- 05/17/2005:
Revised list to add 1 new member, Restricted
List for Clinical Investigators
- 05/05/2005:
Added new biologics compliance program 7345.848 Inspection of Biological Drug Products, and removed four programs
that the new program supersedes: 7341.001, 7342.006, 7345.001, and
7345.002.
- 04/25/2005
Revised CPG 100.700 GWQAP
Pre-Award Evaluation - Inadequate Information to Evaluate Prospective
Supplier
- 04/25/2005
Revised CPG 390.300 Assessment
of Civil Penalties Against Manufacturers and Importers of Electronic
Products
- 04/18/2005:
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990 Updated April 18,
2005
- 04/13/2005
Revised CPG Sec. 560.400 Imported
Milk and Cream - Federal Import Milk Act CPG 7119.05
- 04/12/2005:
Revised Debarment
List, 04/12/2005 - One person added.
- 04/11/2005:
Revised list to add 3 new members,
Restricted List for
Clinical Investigators
- 03/23/2005
Revised list to add one new member; and remove one Application
Integrity Policy List
- 03/18/2005
Revised CPG Sec.
300.500 - Reprocessing of Single Use Devices (CPG 7124.16)
- 03/10/2005
Revised 8 CPGs to make corrections/minor changes: Sec.
390.100; Sec. 390.400; Sec.
393.100; Sec.
396.300; Sec.
398.100; Sec.
398.325; Sec.
398.425; Sec.
398.700;
- 03/10/2005
Revoked CPG: Sec.
355.100 - Cellutron Machine
- 03/08/2005
Revoked 03/08/2005, Compliance Policy Guide, Sec. 160.800 Y2K
Computer Compliance
- 03/08/2005:
Revised list to add 2 new members,
Restricted List for Clinical Investigators
- 03/04/2005:
Revised CPG Sec. 110.310 - Prior
Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
- 02/18/2005:
Draft revised
CPG Sec. 310.210 "Blood Pressure Measurement Devices (Sphygmomanometers)
- Accuracy (CPG 7124.23)
FR Notice
of Availability (PDF)  56.8 KB
Draft
Revision (PDF) 382 KB
- 02/01/2005:
Revised list to add 1 new member,
Restricted List for
Clinical Investigators
- 01/14/2005:
Revised list to add 1 new member,
Disqualified/Totally
Restricted List for Clinical Investigators
- 12/07/2004
Revised Debarment
List, 12/07/2004 - One person added. Published 12/02/2004.
- 11/18/2004
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990 Updated November
18, 2004
- 11/16/2004
New CPG Sec. 400.210- Radiofrequency
Identification Feasibility Studies and Pilot Programs
- 11/03/2004
Revised CPG Sec. 110.300 - Registration
of Food Facilities Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
- 11/02/2004
Revised CPG Sec. 110.310 - Prior
Notice of Imported Food Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
- 10/29/2004
Draft CPG (Not for Implementation), Sec.
560.400 "Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05)." When finalized it will replace the existing CPG at Sec. 560.400. Comments
due 30 days after date of publication in the Federal Register dated
October 29, 2004
- 10/03/2004
Revised list to add 1 new member, Disqualified/Totally
Restricted List for Clinical Investigators
- 08/31/2004
Edited Debarment List - at Uddin, Mohammad, added "NMI" to indicate that
FDA records show no middle initial for this person.
- 08/16/2004
Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
- 07/29/2004
Revised CPG Sec. 394.500 - Importation
of Television Products, Microwave Ovens, and Inherent Class I Laser
Products for Investigation and Evaluation
- 07/29/2004
Replaced/Retitled CPG Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods (CPG
7119.14)
- 07/23/2004
Updated links to FDA Regulations (2004) on the Bioresearch
Monitoring Information Page;
links to laws enforced by FDA and related regulation on the Welcome
to Compliance References page
- 06/24/2004
Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002
- 06/16/2004
AIP Procedures - procedures March 5, 1998
- 06/10/2004
Revised to update citations Sec. 690.300 Canned Pet Food (CPG 7126.18)
- 06/15/2004
Correction in classification (Class) - Charles
River Laboratories, West Chester, OH
- 05/12/2004
John B. Najarian on Restricted
List for Clinical Investigators
- 05/06/2004
March 2004 edition of the Regulatory
Procedures Manual (RPM) published. New edition of FDA RPM is effective
May 6th, 2004. All chapters have been changed except Chapter
9 "Import Operations/Actions."
- 04/09/2004
Corrected entry for Arthur Riba on Restricted
List for Clinical Investigators
- 04/05/2004
Revised Application Integrity
Policy List to add Plus Orthopedics, San Diego, California.
- 3/12/2004
Revised to update content of August 2000 paper edition:
Sec. 490.100 Process
Validation Requirements for Drug Products and Active Pharmaceutical
Ingredients Subject to Pre-Market Approval CPG 7132c.08
- 02/23/2004
Revised list to add 1 new member, 02/23/2004: Restricted
List for Clinical Investigators;
Revised list to add 1 new member, 02/23/2004: Disqualified/Totally
Restricted List for Clinical Investigators
- 02/13/2004
Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990 Updated February
9, 2004
- 2/9/2004
Edited two pages to conform text (reference) on Internet pages to
August 2000 paper edition: CPG Sec. 515.700 Chocolate
& Chocolate Liquor - Adulteration with Insect and Rodent Filth
CPG 7105.11
CPG Sec. 515.775 Cocoa
Powder, Press Cake - Adulteration with Insect and Rodent Filth CPG
7105.13
- Draft CPG 1/14/2004
Draft CPG (Not for Implementation), Sec. 560.750 "Guidance Levels
for Radionuclides in Domestic and Imported Foods, Availability; and
Draft Supporting Document, Supporting Document for Guidance Levels
for Radionuclides in Domestic and Imported Foods." [TXT] [PDF (39kb)] When finalized it will replace the existing CPG. Comments
due March 15, 2004
--The
Draft Guidance Word version (39.5kb)
--The
Draft Guidance PDF (17.2kb)
--Supporting
Statement for Guidance Levels - Word version (151kb)
--Supporting
Statement for Guidance Levels - PDF (59.3kb)
- Revoked 1/5/2004
Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse CPG
7124.06
- New CPG Sec. 110.300 - "Registration of Food Facilities Under
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002" is available at: http://www.cfsan.fda.gov/~furls/cpgreg.html.
- Revised: Application Integrity Policy Committee
Contact Persons list on 12/18/2003
- Revised Application Integrity
Policy List to add AGA Medical Corporation, Golden Valley, Minnesota
- Revised CPGM list on 12/18/2003
by
• added new Drugs program 7356.002M, "Inspections of Licensed
Biological Therapeutic Drug Products"
• added new Veterinary Medicine program 7371.009, "BSE/Ruminant
Feed Ban Inspections"
• added on-line links for Drug programs: 7346.832 "Pre-Approval
Inspections/Investigations"; 7346.843, “Post-Approval Audit
Inspections”; 7356.002A, "Sterile Drug Process Inspections";
7356.002B, “Repackers and Relabelers”, 7356.002C, “Radioactive
drugs” and 7356.002E, “Compressed medical gases”
• Corrected title of drug program 7356.002 "Drug Manufacturing
Inspections"
• corrected CPGM list by removing previously withdrawn Device
programs 7385.002 "Ionizing Radiation Use Control Laboratory
Support", 7385.003 "Federal Facility Use Control and Equipment
Performance Survey Program", and 7386.006G "WEAC Testing
of Medical Devices for Conformance to Voluntary Standards"
• corrected Device program numbers 7382.014 to 7385.014 and
7385.004 to 7386.009.
- New CPG Sec. 110.310 - "Prior Notice of Imported Food Under
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002" is available at: http://www.cfsan.fda.gov/~pn/cpgpn.html.
- Revised Debarment
List, 10/22/2003 - One person added. Published 10/23/03.
- Revised list to add 2 new members, 10/17/2003: Disqualified/Totally Restricted
List for Clinical Investigators. Published 10/21/03.
- Revised Debarment
List, 10/10/2003 - debarment terminated for one person; three
people added. Published 10/10/03.
- Added pdf version of Guideline
for the Monitoring of Clinical Investigations, Jan., 1988. (PDF 16KB). Published 9/30/03.
- Revised list to add 2 new members, 09/09/2003: Restricted List for Clinical
Investigators. Published 09/10/03.
- Revised 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990, Updated 08/11/2003.
Published 09/04/03.
- Revised Debarment
List, 8/8/2003 - one person added. Published 8/15/03.
- Revised Sec.
608.400 - Compounding of Drugs for Use in Animals. Published 7/14/03.
- Revised 3 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990, Updated 01/27/3.
Published 7/2/03.
- New CPGM link to Compliance Programs published by CBER: Inspection of Source
Plasma Establishments and Inspections
of Licensed Vaccines. Published 6/6/03.
- Updated ORA page on Electronic Records/Signatures, 21 CFR Part 11. Published
6/6/03.
- Revised Debarment
List, 5/9/2003 - one person added. Published 5/30/03.
- Revoked effective 02/19/2003: Compliance Policy Guide, Enforcement
Policy: 21 CFR Part 11; Electronic
Records; Electronic Signatures (CPG 7153.17). See: 68 FR 8775 02/25/2003.
Published 5/30/03.
- Revised list to update Dr. J.L. Williams, 5/15/2003: Disqualified/Totally Restricted
List for Clinical Investigators. Published 5/23/03.
- Replaced Reference: Good
Laboratory Practice (GLP) Final Rule, 12/22/1978 (PDF 6585KB). Published 5/23/03.
- Revised - Four Lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990, Updated 03/06/2003.
Published 5/1/03.
- Revised Application Integrity
Policy List to remove Gliatech, Inc., Beachwood, OH; and Solvay
Pharmaceuticals, Inc., Beaudette, MN, and Marietta, GA, April 2003.
- Revised list to add new member, 04/10/2003: Disqualified/Totally Restricted
List for Clinical Investigators.
- Revised Debarment
List on 04/09/2003 - One person removed (Hernandez, Delfina);
One correction inserted (Lai, Elaine).
- Revised: Application
Integrity Policy Committee Contact Persons list. Updated 3/31/2003.
- Revised 03/23/2003, HTML/online links changed for Biologics Compliance Programs 7342.006,
7342.008. and 7345.001 (CBER). No content was changed.
- New CPGM, 03/19/2003: Biologics Compliance Program March 2003, 7341.002, Inspection of Tissue
Establishments (CBER).
- Revoked effective 02/19/2003 - Compliance Policy Guide, Enforcement
Policy: 21 CFR Part 11; Electronic
Records; Electronic Signatures (CPG 7153.17) See: 68
FR 8775 02/25/2003.
- Revised list to add new member, 02/10/2003: Disqualified/Totally Restricted
List for Clinical Investigators.
- Revised Debarment
List on 01/13/2003 - 2 people added.
2002 Revisions and Updates
- Revised list to add new member, 10/28/2002: Disqualified/Totally Restricted
List for Clinical Investigators.
- Edited lists 12/16/2002: 1) Inactive
Labs List and 2)Active
Tox Labs List
- Revised Debarment
List on 12/03/2002 - one person added
- Typographical errors (1 per page) 11/27/2002: CPGuides Manual -
Sec 555.425 -Foods - Adulteration
Involving Hard or Sharp Foreign Objects; and
Sec. 515.350 Candy - Mixed with
Trinkets and Sold in Vending Machines (CPG 7105.04)
- Edited links 11/27/2002: 21 CFR
Part 11 Guidance Documents Dockets Established - Topics for Guidance
Development
- Revised 11/14/2002: Sec. 555.600
Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18)
- Updated 11/14/2002: 4 lists of Nonclinical
Laboratories Inspected Since Fiscal Year 1990
- Revoked effective 11/12/2002: Sec.
398.475 Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic
Systems with Fixed SID and Without Stepless Adjustment of the Field
Size (CPG 7133.17)
- Revised 11/13/2002 Debarment
List - 3 people added
- Revised 2 lists to add new or update member(s), 10/16/2002:
Disqualified/Totally Restricted List for
Clinical Investigators and
Restricted List for Clinical Investigators
- Revoked effective 10/07/2002, Sec.
300.700 Direct Reference Authority for Class III Medical Devices Without
a Premarket Notification (510(k)) or an Approved Premarket Approval
Application (PMA) (CPG 7124.30) per Federal Register, 09/05/2002
(67 FR
56850)
- Revised Subchapter
Import for Export in Chapter 9 of Regulatory Procedures Manual.
09/13/2002.
- New - CryoLife, Inc., Kennesaw, GA, 08/13/2002. Order for
Retention, Recall, and/or Destruction [PDF] size 279KB [HTML]
- New - Four Lists of Nonclinical Laboratories
Inspected Since Fiscal Year 1990. Updated 08/2002
- Revised list to add new member, 08/7/2002:
Disqualified/Totally Restricted List for
Clinical Investigators
- Revoked effective on 08/07/2002:
Sec. 315.200 Status of Dental
Supplies such as Denture Cleaners, Adhesives, Cushions, and Repair
Materials as a Device or Cosmetic (CPG 7124.05) See 67
FR 45129, 07/08/2002
- Revised list to add new member, 06/27/2002:
Restricted List for Clinical Investigators
- Revised list to add new member, 06/27/2002:
Disqualified/Totally Restricted List for
Clinical Investigators
- Reissued 05/29/2002, Sec. 460.200
Pharmacy Compounding
- Revoked effective on 06/20/2002, Sec.
391.100 Advertisement Literature for High-Intensity Mercury Vapor
Discharge Lamps (CPG 7133.13)
- Revoked effective on 06/20/2002, Sec.
396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning
Products (CPG 7133.16)
- Corrected 05/16/2002, Sec 575.100
Pesticide Residues...Heptachlor table
- New CPG Sec. 230.150 Blood
Donor Classification Statement, Paid or Volunteer Donor issued
05/07/2002
- Revised BioResearch Monitoring Information references added or updated 05/16/2002
- Revised Debarment
List on 05/07/2002 - person added
- Revised Compliance Program Manual
04/26/2002 page - page text and links were updated
- Edited Debarment List on 04/09/2002
- Revised as Draft 05/29/2002 - Sec.
345.100 Male Condom Defects (CPG 7124.21) for comment
- Edited page to remove dates that may become obsolete, 04/2/2002:
Application Integrity Policy Information.
- Revised list to add new member, 04/02/2002:
Disqualified/Totally Restricted List for
Clinical Investigators
- Revised list to add new member, 02/20/2002:
Application Integrity Policy List
- Revised lists to align members to groups, 01/15/2002:
a) Restricted List for Clinical Investigators
b) Disqualified/Totally Restricted
List for Clinical Investigators
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