FDA Links -- Specific Audiences

 

1. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 5/1/2008)
    
2. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 4/9/2008)
    
3. Paragraph IV Patent Certifications (updated 2/27/2008)
    
4. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 2/20/2008)
    
5. 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)
    
6. Pediatric Exclusivity Granted (updated 2/15/2008)
    
7. BPCA/Pediatric Exclusivity Statistics (2/12/2008)
   1. Written Requests Issued (updated)
   2. Written Requests Statistics (updated)
       
8. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Updated
   Posted: 2/8/2008; Meeting Date: 4/29-30/2008 (Posted 2/8/2008)
    
9. BPCA/Pediatric Exclusivity Statistics (updated 1/16/1008):
   1. Breakdown of Requested Studies Report
   2. Pediatric Exclusivity Labeling Changes
   3. Spectrum of Diseases/Conditions
       
10. Office of Generic Drugs (updated 1/14/2008):
    1. December First-Time Generic Drug Approvals
    2. Suitability Petitions
        
11. Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan; Federal Register Notice | Draft Guidance (PDF, 1/4/2008)
     
12. Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/31/2007)
     
13. Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
     
14. Drug Safety Oversight Board Meeting, December 6, 2007, Public Summary (12/26/2007)
     
15. BPCA/Pediatric Exclusivity Statistics: Written Requests Issued (updated 12/21/2007)
     
16. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 12/13/2007)
     
17. Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/12/2007)
     
18. Public Meeting on Essential Uses of Ozone Depleting Substances December 5, 2007, Rockville, MD (Posted 12/12/2007)
    1. Meeting Transcript (PDF)
    2. Meeting Presentation (PDF)
        
19. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 12/7/2007)
     
20. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 11/15/2007)
    2. Pediatric Exclusivity Labeling Changes (updated 11/15/2007)
        
21. Office of Generic Drugs:
    1. Requesting a Pre-Assigned Electronic Common Technical Document (eCTD) Number from Office of Generic Drugs (10/31/2007)
        
22. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 10/26/2007)
     
23. 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)
     
24. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 10/25/2007)
        
25. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 10/16/2007)
     
26. PDUFA Information:
    1. Prescription Drug User Fee Rates for Fiscal Year 2008 (PDF, 10/10/2007)
        
27. BPCA/Pediatric Exclusivity Statistics:
    1. Breakdown of Requested Studies Report (updated 10/9/2007)
    2. Pediatric Exclusivity Statistics (updated 10/9/2007)
    3. Spectrum of Diseases/Conditions (updated 10/9/2007)
    4. Written Requests Issued (updated 10/9/2007)
        
28. PDUFA Information:
    1. Notice to Applicants Submitting Direct-to-Consumer Television Advertisements for Advisory Review to CDER/CBER for Fiscal Year 2008 (10/1/2007)
        
29. Paragraph IV Patent Certifications (updated 9/24/2007)
     
30. New PDUFA payment procedures for application and supplement fees effective October 1, 2007 (9/17/2007)
     
31. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 9/7/2007)
    2. Pediatric Exclusivity Statistics (updated 9/7/2007)
    3. Written Requests Issued (updated 9/7/2007)
        
32. Pediatric Research Equity Act (PREA) Labeling Changes (updated 9/4/2007)
     
33. Office of Generic Drugs:
    1. Update on Question-based Review Submissions (8/10/2007)
     
34. Office of Generic Drugs:
    1. July First-Time Generics (8/9/2007)
        
35. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 8/9/2007)
     
36. 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)
     
37. Implementation of Risk Minimization Action Plans (RiskMAPs), June 25-26, 2007: Public Meeting Presentations (6/28/2007)
     
38. Office of Generic Drugs:
    1. May First-Time Generics (6/15/2007)
        
39. BPCA/Pediatric Exclusivity Statistics:
    1. Written Requests Issued (updated 6/11/2007)
    2. Written Requests Statistics (updated 6/11/2007)
        
40. 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)
     
41. Presentations from the FDA/Small Business Administration Drug Educational Forum, April 25, 2007 (5/1/2007)
     
42. Office of Generic Drugs:
    1. Paragraph IV Patent Certifications (updated 4/30/2007)
        
43. Genomics Presentation: The Transition from Pre-Clinical to Clinical Application of Safety Related Related Genomics (PDF,  4/25/2007)
     
44. Office of Generic Drugs:
    1. FDA addresses issues on Amlodipine Abbreviated New Drug Application Approvals (4/19/2007)
        
45. BPCA/Pediatric Exclusivity Statistics:
    1. Breakdown of Requested Studies Report (updated 4/10/2007)
    2. Pediatric Exclusivity Statistics (updated 4/10/2007)
    3. Spectrum of Diseases/Conditions (updated 4/10/2007)
    4. Written Requests Issued (updated 4/10/2007)
        
46. Office of Nonprescription Products:
    1. Rx-to-OTC Switch List (4/4/2007)
     
47. Office of Generic Drugs:
    1. FDA solicits comments on Amlodipine Abbreviated New Drug Application Approval issues (3/30/2007)
        
48. Office of Nonprescription Products:
    1. Rulemaking History for Nonprescription Products (3/29/2007)
        
49. International Conference on Harmonization (ICH) Public Meeting Friday, April 6, 2007, Rockville, MD. Meeting Information (3/27/2007)
     
50. Pediatrics: PREA Labeling Changes (3/23/2007)
     
51. Office of Generic Drugs:
    1. Approved Discontinued Drug Products Safety and Effectiveness Determinations (PDF, 3/20/2007)
        
52. Genomics presentations (3/12/2007)
    1. Update on the Critical Path and Personalized Medicine Initiative Implementation [PDF]
    2. Clarifying the Current Regulatory Position on the Validation and Standardization of Biomarkers for Approval and Ongoing Patient Care [PDF]
        
53. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Statistics (updated 3/9/2007)
    2. Written Requests Issued (updated 3/9/2007)
        
54. FDA Drug Educational Forum; Public Workshop for Small Business, April 25, 2007. Meeting Information (2/15/2007)
     
55. Consumer Healthcare Products Association (CHPA) / FDA Joint Seminar Series (2/12/2007)
     
56. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Statistics (updated 2/8/2007)
    2. Written Requests Issued (updated 2/8/2007)
        
57. Office of Generic Drugs:
    1. Paragraph IV Patent Certifications (updated 2/8/2007)
        
58. Office of Generic Drugs: Model Bioequivalence Data Summary Tables (1/29/2007)
     
59. Office of Nonprescription Products:
    1. Rulemaking History for Nonprescription Products: Internal Analgesic, Antipyretic, Antirheumatic Drug Products (updated 12/27/2006)
     
60. Drug Safety Oversight Board Meeting Public Summary for October 26, 2006 (12/13/2006)
     
61. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 12/12/2006)
        
62. Office of Nonprescription Products:
    1. Rulemaking History for Nonprescription Products: Labeling (12/12/2006)
        
63. BPCA/Pediatric Exclusivity Statistics
    1. Pediatric Exclusivity Statistics (updated 12/7/2006)
    2. Written Requests Issued (updated 12/7/2006)
        
64. National Surveys of Prescription Medicine, Information Received by Consumers (12/4/2006)
     
65. BPCA/Pediatric Exclusivity Statistics (Updated 11/28/2006):
    1. Pediatric Exclusivity Granted (updated)
    2. Pediatric Exclusivity Labeling Changes (updated)
        
66. Office of Nonprescription Products: How FDA Regulates OTC Drugs (11/22/2006)
     
67. 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)
     
68. BPCA/Pediatric Exclusivity Statistics
    1. Pediatric Exclusivity Granted (updated 11/13/2006)
        
69. 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)
     
70. BPCA/Pediatric Exclusivity Statistics
    1. Breakdown of Requested Studies Report (updated 10/12/2006)
    2. Pediatric Exclusivity Granted (updated 10/2/2006)
    3. Pediatric Exclusivity Statistics (updated 10/12/2006)
    4. Spectrum of Diseases/Conditions (updated 10/12/2006)
        
71. Office of Nonprscription Products
    1. Advisory Committee Meetings: Improving FDA and Industry Collaboration; FDA/CDER-CHPA Seminar Series; Fall Seminar; September 27, 2006 (PDF, 10/3/2006)
    2. Abbreviated Timeline (PDF, 10/3/2006)
     
72. BPCA/Pediatric Exclusivity Statistics
    1. Pediatric Exclusivity Granted (updated 10/2/2006)
        
73. Office of Generic Drugs: FDA's Clarification of Aripiprazole Tablets' Bioequivalence Requirements  (PDF, 9/28/2006)
     
74. Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels (9/15/2006)
     
75. BPCA/Pediatric Exclusivity Statistics
    1. Pediatric Exclusivity Granted (updated 9/14/2006)
    2. Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies (updated 9/14/2006)
        
76. BPCA/Pediatric Exclusivity Statistics
    1. Written Requests Issued (updated 9/12/2006)
    2. Pediatric Exclusivity Statistics (updated 9/12/2006)
        
77. Office of Nonprescription Products
    1. Rulemaking History for OTC Drug Products (updated 8/29/2006)
    2. Consumer Information (updated 8/29/2006)
        
78. BPCA/Pediatric Exclusivity Statistics
    1. Pediatric Exclusivity Granted (updated 8/29/2006)
    2. Pediatric Exclusivity Statistics (updated 8/29/2006)
        
79. 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)
     
80. Public Workshop on Emerging Clostridial Disease (updated 8/21/2006)