|
|
|
|
|
FDA Links -- Specific Audiences
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes (updated 5/1/2008)
- BPCA/Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Granted (updated 4/9/2008)
-
Paragraph IV Patent Certifications
(updated 2/27/2008)
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes
(updated 2/20/2008)
-
Pediatric Exclusivity Determinations Made under Section
505A of the Federal Food, Drug, and Cosmetic Act (the Act), as amended
by the FDA Amendments Act of 2007 (FDAAA)
(updated 2/15/2008)
-
Pediatric Exclusivity Granted (updated
2/15/2008)
- BPCA/Pediatric Exclusivity Statistics
(2/12/2008)
-
Written Requests Issued (updated)
-
Written Requests Statistics (updated)
-
Public Workshop: Safety of Hemoglobin-Based Oxygen
Carriers (HBOCs) - Updated
Posted: 2/8/2008; Meeting Date: 4/29-30/2008
(Posted 2/8/2008)
- BPCA/Pediatric Exclusivity Statistics (updated 1/16/1008):
-
Breakdown of Requested Studies Report
-
Pediatric Exclusivity Labeling Changes
-
Spectrum of Diseases/Conditions
- Office of Generic Drugs (updated
1/14/2008):
-
December First-Time Generic Drug Approvals
-
Suitability Petitions
- Draft Prescription Drug User Fee Act (PDUFA)
IV Information Technology Plan;
Federal
Register Notice |
Draft Guidance (PDF, 1/4/2008)
- Best Pharmaceuticals for Children Act of
2007:
List of Determinations including Written Request (updated
12/31/2007)
-
Certification to Accompany Drug, Biological Product, and
Device Applications or Submissions
(12/26/2007)
-
Drug Safety Oversight Board Meeting, December 6, 2007,
Public Summary (12/26/2007)
- BPCA/Pediatric Exclusivity Statistics:
Written Requests
Issued (updated 12/21/2007)
- BPCA/Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Granted (updated 12/13/2007)
- Best Pharmaceuticals for Children Act of
2007:
List of Determinations including Written Request (updated
12/12/2007)
-
Public Meeting on Essential Uses of Ozone
Depleting Substances December 5, 2007, Rockville, MD (Posted
12/12/2007)
-
Meeting Transcript (PDF)
-
Meeting Presentation (PDF)
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes (updated 12/7/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric Exclusivity Granted (updated
11/15/2007)
-
Pediatric Exclusivity Labeling Changes
(updated 11/15/2007)
- Office of Generic Drugs:
-
Requesting a Pre-Assigned Electronic Common Technical Document (eCTD)
Number from Office of Generic Drugs (10/31/2007)
- Office of Nonprescription Products:
Rulemaking History for Nonprescription Products (updated 10/26/2007)
- 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 [HTML]
[PDF]
(10/25/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric Exclusivity Granted (updated
10/25/2007)
- Office of Nonprescription
Products:
Rulemaking History for Nonprescription Products (updated
10/16/2007)
- PDUFA
Information:
-
Prescription Drug User Fee Rates for Fiscal Year 2008
(PDF, 10/10/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Breakdown of Requested Studies Report
(updated 10/9/2007)
-
Pediatric Exclusivity Statistics
(updated 10/9/2007)
-
Spectrum of Diseases/Conditions
(updated 10/9/2007)
-
Written Requests Issued (updated 10/9/2007)
- PDUFA Information:
-
Notice to Applicants Submitting Direct-to-Consumer
Television Advertisements for Advisory Review to CDER/CBER for Fiscal
Year 2008 (10/1/2007)
-
Paragraph IV Patent Certifications
(updated 9/24/2007)
-
New PDUFA payment procedures for application and
supplement fees effective October 1, 2007
(9/17/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric Exclusivity Granted (updated
9/7/2007)
-
Pediatric Exclusivity Statistics (updated
9/7/2007)
-
Written Requests Issued (updated 9/7/2007)
-
Pediatric Research Equity Act (PREA) Labeling Changes
(updated 9/4/2007)
-
Office of Generic Drugs:
-
Update on Question-based Review Submissions (8/10/2007)
- Office of Generic Drugs:
-
July First-Time Generics
(8/9/2007)
- Pediatric Exclusivity Statistics:
Pediatric
Exclusivity Labeling Changes (updated 8/9/2007)
-
Summary of Public Workshop:
(PFD) Implementation of Risk Minimization Action Plans (RiskMAPs)
to Support Quality Use of Pharmaceuticals: Opportunities and
Challenges June, 2007 (7/20/2007)
-
Implementation of Risk Minimization Action Plans (RiskMAPs),
June 25-26, 2007: Public Meeting Presentations
(6/28/2007)
- Office of Generic Drugs:
-
May First-Time Generics
(6/15/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Written Requests Issued (updated 6/11/2007)
-
Written Requests Statistics
(updated 6/11/2007)
-
In anticipation of FY 2008, the FY 2008 Dear Colleague letter
requesting PDUFA information from firms was mailed out May 4, 2007.
PDUFA information
(5/4/2007)
-
Presentations from the FDA/Small Business Administration
Drug Educational Forum, April 25, 2007
(5/1/2007)
-
Office of Generic Drugs:
-
Paragraph IV Patent
Certifications (updated 4/30/2007)
- Genomics Presentation:
The Transition from Pre-Clinical to Clinical Application of Safety
Related Related Genomics (PDF, 4/25/2007)
-
Office of Generic Drugs:
-
FDA addresses
issues on Amlodipine Abbreviated New Drug Application Approvals
(4/19/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Breakdown
of Requested Studies Report (updated 4/10/2007)
-
Pediatric
Exclusivity Statistics (updated 4/10/2007)
-
Spectrum of
Diseases/Conditions (updated 4/10/2007)
-
Written
Requests Issued (updated 4/10/2007)
-
Office of Nonprescription Products:
-
Rx-to-OTC
Switch List (4/4/2007)
- Office of Generic Drugs:
-
FDA solicits comments on Amlodipine Abbreviated New Drug Application
Approval issues (3/30/2007)
- Office of Nonprescription Products:
-
Rulemaking History for Nonprescription Products (3/29/2007)
- International Conference on Harmonization (ICH) Public Meeting Friday,
April 6, 2007, Rockville, MD.
Meeting
Information (3/27/2007)
- Pediatrics:
PREA Labeling Changes (3/23/2007)
- Office of Generic Drugs:
-
Approved Discontinued Drug Products Safety and Effectiveness
Determinations (PDF, 3/20/2007)
-
Genomics presentations (3/12/2007)
- Update on the Critical Path and Personalized Medicine Initiative
Implementation [PDF]
- Clarifying the Current Regulatory Position on the Validation and
Standardization of Biomarkers for Approval and Ongoing Patient Care [PDF]
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric
Exclusivity Statistics (updated 3/9/2007)
-
Written
Requests Issued (updated 3/9/2007)
- FDA Drug Educational Forum; Public Workshop for Small Business, April
25, 2007.
Meeting Information (2/15/2007)
-
Consumer Healthcare Products Association (CHPA) / FDA Joint Seminar Series
(2/12/2007)
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric
Exclusivity Statistics (updated 2/8/2007)
-
Written
Requests Issued (updated 2/8/2007)
- Office of Generic Drugs:
-
Paragraph IV Patent
Certifications (updated 2/8/2007)
- Office of Generic Drugs:
Model
Bioequivalence Data Summary Tables (1/29/2007)
-
Office of Nonprescription Products:
-
Rulemaking History for Nonprescription Products: Internal Analgesic,
Antipyretic, Antirheumatic Drug Products (updated 12/27/2006)
-
Drug Safety Oversight Board Meeting Public Summary for October 26, 2006
(12/13/2006)
- BPCA/Pediatric Exclusivity Statistics:
-
Pediatric
Exclusivity Granted (updated 12/12/2006)
- Office of Nonprescription Products:
-
Rulemaking History for Nonprescription Products: Labeling (12/12/2006)
-
BPCA/Pediatric Exclusivity Statistics
-
Pediatric
Exclusivity Statistics (updated 12/7/2006)
-
Written
Requests Issued (updated 12/7/2006)
-
National
Surveys of Prescription Medicine, Information Received by Consumers
(12/4/2006)
- BPCA/Pediatric Exclusivity Statistics (Updated 11/28/2006):
-
Pediatric
Exclusivity Granted (updated)
-
Pediatric Exclusivity Labeling Changes (updated)
- Office of Nonprescription Products:
How FDA
Regulates OTC Drugs (11/22/2006)
-
Presentation to the American Public Health Association, November 6,
2006, Steven K. Galson, M.D., M.P.H., CDER Center Director (PDF,
11/21/2006)
- BPCA/Pediatric Exclusivity Statistics
-
Pediatric
Exclusivity Granted (updated 11/13/2006)
-
FDA is extending the expiration date to May 1, 2007 for the use of the
prior version of Form FDA 3500A for "MedWatch: Food and Drug
Administration Medical Products Reporting Program" (the MedWatch Program).
Federal Register
Notice (PDF)
MedWatch Reporting Forms (10/20/2006)
-
BPCA/Pediatric Exclusivity Statistics
-
Breakdown
of Requested Studies Report (updated 10/12/2006)
-
Pediatric
Exclusivity Granted (updated 10/2/2006)
-
Pediatric
Exclusivity Statistics (updated 10/12/2006)
-
Spectrum of
Diseases/Conditions (updated 10/12/2006)
-
Office of Nonprscription Products
-
Advisory Committee Meetings: Improving FDA and Industry Collaboration;
FDA/CDER-CHPA Seminar Series; Fall Seminar; September 27, 2006 (PDF,
10/3/2006)
-
Abbreviated Timeline (PDF, 10/3/2006)
- BPCA/Pediatric Exclusivity Statistics
-
Pediatric
Exclusivity Granted (updated 10/2/2006)
- Office of Generic Drugs:
FDA's Clarification of Aripiprazole Tablets' Bioequivalence Requirements
(PDF, 9/28/2006)
-
Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels
(9/15/2006)
- BPCA/Pediatric Exclusivity Statistics
-
Pediatric
Exclusivity Granted (updated 9/14/2006)
-
Summaries
of Medical and Clinical Pharmacology Reviews of Pediatric Studies
(updated 9/14/2006)
- BPCA/Pediatric Exclusivity Statistics
-
Written Requests
Issued (updated 9/12/2006)
-
Pediatric
Exclusivity Statistics (updated 9/12/2006)
- Office of Nonprescription Products
-
Rulemaking History for OTC Drug Products
(updated 8/29/2006)
-
Consumer Information (updated
8/29/2006)
- BPCA/Pediatric Exclusivity Statistics
-
Pediatric Exclusivity Granted
(updated 8/29/2006)
-
Pediatric Exclusivity Statistics
(updated 8/29/2006)
-
Approved Active Moieties for which FDA has Issued a Written Request for
Pediatric Studies under Section 3 of the Best Pharmaceuticals for
Children Act (updated 8/22/2006)
-
Public Workshop on Emerging Clostridial Disease
(updated 8/21/2006)

|
|