FDA Home Page | Dockets Home Page | Dockets
Contacts and Location | Operating Status
Note:
Many of the documents are in PDF format, and need the Adobe Acrobat
Reader to review the files. Click on the Adobe icon below to download
the free reader. |
|
Dockets beginning in the year: 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998 | 1997 | 1996 - 1976 | What's New |
|
Year 2007 NOTE: All 2007 Citizen Petitions can now be accessed at Regulations.gov. |
|
Docket No. |
Title of Docket |
Request for Comments on the Science and Technology
Report; Establishment of Docket; Request for Comment (New
2/19/08) | |
Meeting being Planned to Obtain Public Input for
Ensuring the Safety of Pet Food (New 1/8/08) | |
Prescription Drug User Fee Act (PDUFA) IV Information
Technology Plan (New 1/3/08) | |
Maximizing the Public Health Benefit of Adverse Event
Collection Throughout a Products Marketed Life Cycle; Public Workshop
(New 3/17/08) | |
Acarbose Tablets and 180-Day Exclusivity (Updated
11/15/07) | |
Drug-Induced Liver Injury: Premarketing Clinical
Evaluation;Draft Guidance (New 1/16/08) | |
Guidance for Industry on Acute Bacterial Sinusitis:
Developing Drugs for Treatment (New 10/30/07) | |
Guidance for Industry: Blood Establishment Computer
System Validation in the Users Facility (New 10/31/07) | |
User Fee Program for Advisory Review of Direct-to-Consumer
Television Advertisements for Prescription Drug and Biological Products;
Request for Notification of Participation and Number of Advertisements
for Review (New 11/1/07) | |
Granisetron Hydrochloride Injection and 180-day
Generic Drug Exclusivity (Updated 12/18/07) | |
Ramipril Capsules and 180-day generic drug exclusivity
(Updated 12/18/07) | |
Biomin GmbH; Filing of Food Additive Petition (FAP
2256) (New 10/30/07) | |
Impact-Resistant Lenses: Questions and Answers Guidance
(New 10/31/07) | |
Guidance for Industry: Cell Selection Devices for
Point of Care Production of Minimally Manipulated Autologous Peripheral
Blood Stem Cells (PBSCs) (New 12/6/07) | |
Ramipril Capsules and 180-day generic drug exclusivity
(New 12/18/07) | |
Advisory Opinion Request to List Certian Types of
Patents in the Orange Book (New 10/29/07) | |
Food ALlergen Labeling Petition (FALP): Soy Lecithin
when used as Processing Aids (New 6/22/07)
| |
Guidance for Industry and Food and Drug Administration
Staff; Premarket Notification (510(k)) Submissions for Medical Devices
That Include Antimicrobial Agents (New 1/4/08) | |
Health Claim Notification: Unsaturated Fatty Acids
and Risk of Heart Disease (New 5/25/07) | |
Petition to Request an Exemption from 100 Percent
Identity Testing of Dietary Ingredients: Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary Supplements (New 10/30/07) | |
Draft Guidances for Industry Describing Product-Specific
Bioequivalence Recommendations (New 1/28/08)
| |
Defining and Implementing Quality in Clinical Investigations:
From Design to Completion; Public Workshop (New
7/20/07) | |
Amlodipine Abbreviated New Drug Application Approvals
(Updated 5/9/07) | |
Use of Medication Guides to Distribute Drug Risk
Information to Patients; Public Hearing (New 7/18/07)
| |
Electronic Distribution of Prescribing Information
for Prescription Drug Products; Public Hearing (Updated
4/24/07) | |
Guidance for the Public, FDA Advisory Committee
Members, and FDA Staff on Procedures for Determining Conflict of Interest
and Eligibility for Participation in FDA Advisory Committees (New
6/4/07) | |
Guidance for Industry and Review Staff on Target
Product Profile A Strategic Development (New 6/4/07) | |
Medical Device User Fee and Modernization Act: Public
Meeting (New 5/18/07) | |
Safety of Fresh Produce; Public Hearings (Updated
6/13/07) | |
Guidance for Industry on Developing Products for
Weight Management (New 4/20/07) | |
Guidance for Industry; Advisory Committee Meetings:
Preparation and Public Availability of Information Given to Advisory
Committee Members (Udated 6/219/07) | |
Sentinel Network To Promote Medical Product Safety
(New 3/29/07) | |
Agency Information Collection Activities; Proposed
Collection; Comment Request; Adoption of the FDA Food Code by Local,
State, and Tribal Governments (New 4/18/07) | |
Patent Extension Application for IONSYS (fentanyl
iontophoretic transdermal system), U.S. Patent No. 6,425,892 (New
4/10/07) | |
Patent Extension Application for Lantus (insulin
glargine rDNA origin), U.S. Patent No. 5,101,013 (New
4/10/07) | |
Patent Extension Application for Chantix (varenicline),
U.S. Patent No. 6,410,550 (New 3/8/07) | |
Prescription Drug User Fee Act (PDUFA): Public Meeting
(Updated 5/ 15/07) | |
Patent Extension Application for ELAPRASE (idursulfase),
U.S. Patent No. 5,932,211 (New 3/30/07) | |
Patent Extension Application for METVIXIA (methyl
aminoevulinate hydrochloride), U.S. Patent No. 6,034,267 (New
3/30/07) |
Page updated July 21, 2008 kk
Dockets Home Page | Dockets
Contacts and Location | Operating Status|
Item Code
Definitions | Federal
Register
FDA Home Page | Search FDA
Site | A-Z Index | Contact
FDA | Privacy | Accessibility
Division of Dockets Management