Dockets

Year 2007

NOTE: All 2007 Citizen Petitions can now be accessed at Regulations.gov.

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Drug-Induced Liver Injury: Premarketing Clinical Evaluation;Draft Guidance (New 1/16/08)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)

Midodrine Exclusivity Issues (New 8/17/07)

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)