Fall 2001
- Updated: (October 2, 2001) on ORA
Training, Communication Skills:
- Updated: (October 1, 2001) on ORA
Training, Communication Skills:
- Update/New: (September 28, 2001) Federal-State Relations: Calendar of State and National
Meetings - FY 2002
- New: (September 13, 2001) on Frequently
Requested ORA documents and 483s link to four Inspectional Observations files:
- Update: (September 07, 2001) ORA Training courses, Satellite Course Announcements:
Communication
Skills for Regulators, updated 12 course support material files.
- New: (September 04, 2001) Federal-State Relations SAIL Newsletter, Summer 2001 Issue
Page Top
Summer 2001
Page Top
Spring, 2001
- Link Update: (May 18, 2001) Compliance Reference, obsolete page: /ora/compliance_ref/part11/frs/background/pt11finr.txt
redirected to existing page: /ora/compliance_ref/part11/frs/background/11cfr-fr.htm
Updated:Compliance Reference; Compliance Policy Guide, Chapter
4:
/ora/compliance_ref/cpg/cpgdrg/default.htm
- Update: (May 11, 2001) Inspection Reference, Field Management
Directives: FMD 30 ORA Advisory Committee
System and FMD 56 ORA Weekly
Management Review
- New: (May 3, 2001) Inspection Reference: Guidance for FDA
investigators inspecting food establishments for allergenic substance contamination
Updated: Inspection Reference: Guides to
Inspections focus page
- New: (Apr 27, 2001) Industry Assistance: Quality Systems/Good Manufacturing
Practices Survey/Report
Updated: Compliance Reference, CPG
pages:
- Updated: (Apr 26, 2001) Compliance Reference, CPG page: /ora/compliance_ref/cpg/cpgfod/cpg555-250.htm
Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food
Allergens
- New: (Apr 23, 2001) Compliance Reference, CPG pages:
Updated: Compliance Reference, CPG pages:
- New: (Apr 19, 2001) Federal-State Relations, National Food Safety
System Project (NFSS) pages:
Updated: Federal-State focus pages:
- Correction (Apr 18, 2001) Compliance Reference, BIMO left margin
navigation broken links corrected on pages:
Updated: (Apr 18, 2001) Compliance Reference, BIMO Background page /ora/compliance_ref/bimo/background.html
- Updated: (Apr 11, 2001) Inspection Reference, FMD145 Procedure for Release of Establishment
Inspection Report to the Inspected Establishment.
- Updated: (Apr 9, 2001) Compliance Reference, Bioresearch Monitoring,
Good Laboratory Practice: Compliance Program 7348.808 (Nonclinical Laboratories), 10 pages
and PDF Attachment, Date of Issuance: February 21, 2001
Compliance Reference, Bioresearch Monitoring, Compliance Program 7348.810 Sponsors,
Contract Research Organizations and Monitors, Date of Issuance: February 21, 2001, 9 pages
and PDF Attachment, Date of Issuance: February 21, 2001
- Updated (Mar 30, 2001) Federal-State Relations, Calendar of State Meetings
- Updated (Mar 30, 2001) Compliance Reference, CPGs, Biologics:
CPG Revision History,
CPG Biologics Contents,
CPG 220-100,
CPG 270-100
- Updated (Mar 30, 2001) Federal-State Relations, State Food Safety Taskforces
- Updated (Mar 29, 2001) Inspection Reference, IOM 2001 Investigation Operations Manual the
primary source of guidance regarding Agency policy and procedures for field investigators
and inspectors.
- New (Mar 28, 2001) Federal-State Relations, Small Business Guide,
 PDF format guide
(71K).
- New (Mar 21, 2001) Frequently Requested Documents, Eli Lilly and Company, Indianapolis, IN Inspection
January 29 to February 23, 2001, Warning Letter, FDA 483 and responses from firm with
links to PDF
format files.
- Update/New (Mar 21, 2001) Compliance Reference Regulatory Procedures
Manual, Revisions page updated with link
to new file: Chapter 5: Small
Entities, Reduction of Civil Money Penalties
- Update Log Resumed (Mar 21, 2001) A problem with the ORA
staging/development server delayed updates to this log between 09-Feb-2001 and
21-Mar-2001.
- New (Feb 23, 2001) Federal-State Relations, State Food Safety Taskforces
files: progress reports,
grant example ( PDF), RFA grant application.
- Updated/New (Feb 12, 2001) Federal-State Relations, Directory of State/local officials, Food Conference Proceedings ( PDF 648K), Public Affairs Specialists regional
locations, (text version), State Associations, Small
Business: Regions list, SBRs list, Regional Small Business Representatives
(text), Southeast list, Southwest list.
- Updated (Feb 9, 2001) Federal-State Relations, DFSR Public Affairs Specialists
Regional Locations and Public
Affairs Specialists
- New (Feb 7, 2001) Compliance Reference, Compliance Program Manual
(CPGM), 7382-845 Inspections of Medical Device
Manufacturers in HTML, MS Word and PDF formats.
- Corrected (Feb 7, 2001) FIARS: FDA Import Alerts page restored after batch
processing problem.
- Updated (Feb 2, 2001) FMD 17: ORA Field Assignments-Guidelines for
Issuance by Headquarters /ora/inspect_ref/fmd/fmd17.htm
- Updated (Jan 30, 2001) Disqualified/ Restricted/ Assurances List for
Clinical Investigators /ora/compliance_ref/bimo/dis_res_assur.htm
- Updated (Jan 19, 2001) Imports, General Information on the Product Code
Builder, /ora/import/prodbldr/gener2a.html
concerning discontinuation of the PC based product code builder which has been replaced by
an online Web based product code builder and tutorial at www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM.
- New/Update (Jan 18, 2001) Compliance Reference, Application Integrity
Policy pages; updated: /ora/compliance_ref/aiplist.htm,
for link to:
/ora/compliance_ref/Gliatech_AIP_redacted.pdf,(new) and
reformatting of:
/ora/compliance_ref/aip_page.html,
/ora/compliance_ref/aip_points.html,
/ora/compliance_ref/AIP_Contacts.htm,
/ora/compliance_ref/rpm_new2/rpm10aip.html.
- New (Jan 12, 2001) Compliance Reference, Revisions Page, Regulatory Procedures Manual
(RPM), Chapter 9, January 2001, Communication
Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases
Involving Imported Food, and Secured Storage.
- New (Jan 05, 2001) Compliance Reference, Compliance Program Manual
(CPGM), Pilot Program pages CPGM Contents page and Drug Manufacturing Inspections (Pilot
Program) draft for 6 pilot districts only.
- Updated (Jan 04, 2001) Compliance Reference, Compliance Program guides,
updated pages CPG Chapter 3 Devices
Page and Revoked Sec. 305.100
Acupuncture Devices and Accessories (CPG 7124.11)
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