FDA Links -- Specific Audiences

 

1. Breakdown of FDAAA Completed Pediatric Studies (updated 7/22/2010)
    
2. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 7/21/2010)
    
3. BPCA/Pediatric Exclusivity Statistics (Updated: 7/14/2010):
   1. Pediatric Exclusivity Statistics)
   2. Written Requests Issued
       
4. Paragraph IV Patent Certifications (updated 7/9/2010)
    
5. Bioresearch Monitoring Information System (BMIS) (updated 6/31/2010)
    
6. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 6/1/2010)
    
7. BPCA/Pediatric Exclusivity Statistics (updated 4/9/2010):
   1. Pediatric Exclusivity Statistics
   2. Spectrum of Diseases/Conditions
   3. Written Requests Issued
   4. Written Request Template (new template available)
       
8. Pediatric Drug Development: Breakdown of FDAAA Completed Pediatric Studies (updated 3/24/2010)
    
9. Paragraph IV Patent Certifications (updated 3/22/2010)
    
10. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Statistics (updated 3/10/2010)
     
11. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 2/24/2010)
     
12. Bioresearch Monitoring Information System Database (updated 2/10/2010)
     
13. BPCA/Pediatric Exclusivity Statistics (updated 2/4/2010)
    1. Pediatric Exclusivity Statistics
    2. Written Requests Issued
        
14. Paragraph IV Patent Certifications (updated 1/11/2010)
     
15. Adverse Event Reporting System (AERS) Statistics (As of September 30, 2009) (12/31/2009)
     
16. Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated 8/5/2009)
     
17. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 7/8/2009)
     
18. BPCA/Pediatric Exclusivity Statistics: Breakdown of Requested Studies Report (updated 7/7/2009)
     
19. Paragraph IV Patent Certifications (updated 6/15/09)
     
20. BPCA/Pediatric Exclusivity Statistics (updated 6/3/2009)
     
21. Adverse Event Reporting System (AERS) Statistics (updated 5/18/2009)
     
22. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 5/11/2009)
     
23. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 5/6/2009)
     
24. Office of Generic Drugs (updated 4/8/2009)
    1. March First-Time Generic Drug Approvals
        
25. Prescription Drug User Fee Act (PDUFA) Billable Products (PDF, updated 4/6/2009)
     
26. Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book (updated 2/17/2009)
     
27. Bioresearch Monitoring Information System (BMIS) File (Updated, 1/28/2009)
     
28. Pediatric Exclusivity Labeling Changes (updated 1/21/09)
     
29. Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated 12/26/2008)
     
30. Pediatric Exclusivity Statistics (updated 12/8/2008)
     
31. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 10/27/2008)
     
32. Accelerated Approvals under 21 CFR 314 Subpart H (drugs) and 21 CFR 601 Subpart E (biologics) (updated 7/25/2008)
     
33. BPCA/Pediatric Exclusivity Statistics (updated 6/13/2008):
    1. Pediatric Exclusivity Granted
    2. Written Requests Issued
    3. Written Requests Statistics
        
34. 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)
     
35. Pediatric Exclusivity Granted (updated 2/15/2008)
     
36. BPCA/Pediatric Exclusivity Statistics (2/12/2008)
    1. Written Requests Issued (updated)
    2. Written Requests Statistics (updated)
        
37. Public Workshop: Safety of Hemoglobin-Based Oxygen Carriers (HBOCs) - Updated
    Posted: 2/8/2008; Meeting Date: 4/29-30/2008 (Posted 2/8/2008)
     
38. BPCA/Pediatric Exclusivity Statistics (updated 1/16/1008):
    1. Breakdown of Requested Studies Report
    2. Pediatric Exclusivity Labeling Changes
    3. Spectrum of Diseases/Conditions
        
39. Office of Generic Drugs (updated 1/14/2008):
    1. December First-Time Generic Drug Approvals
    2. Suitability Petitions
        
40. Draft Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan; Federal Register Notice | Draft Guidance (PDF, 1/4/2008)
     
41. Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/31/2007)
     
42. Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (12/26/2007)
     
43. Drug Safety Oversight Board Meeting, December 6, 2007, Public Summary (12/26/2007)
     
44. BPCA/Pediatric Exclusivity Statistics: Written Requests Issued (updated 12/21/2007)
     
45. BPCA/Pediatric Exclusivity Statistics: Pediatric Exclusivity Granted (updated 12/13/2007)
     
46. Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request (updated 12/12/2007)
     
47. 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)
        
48. Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated 12/7/2007)
     
49. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 11/15/2007)
    2. Pediatric Exclusivity Labeling Changes (updated 11/15/2007)
        
50. Office of Generic Drugs:
    1. Requesting a Pre-Assigned Electronic Common Technical Document (eCTD) Number from Office of Generic Drugs (10/31/2007)
        
51. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 10/26/2007)
     
52. 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)
     
53. BPCA/Pediatric Exclusivity Statistics:
    1. Pediatric Exclusivity Granted (updated 10/25/2007)
        
54. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 10/16/2007)
     
55. PDUFA Information:
    1. Prescription Drug User Fee Rates for Fiscal Year 2008 (PDF, 10/10/2007)
        
56. 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)
        
57. 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)
        
58. Paragraph IV Patent Certifications (updated 9/24/2007)
     
59. New PDUFA payment procedures for application and supplement fees effective October 1, 2007 (9/17/2007)
     
60. 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)