Internet for Pharmaceutical and Biotech Communities
| Newsletter | Post Jobs | Advertising |
 
 

 

  

Pharm/Biotech Resources

Outsourcing Guide

Cont. Education

Software/Reports

Training Courses

Web Seminars

Jobs

Buyer's Guide

Home Page

Pharm Patents /
Licensing

Pharm News

Federal Register

Pharm Stocks

FDA Links

FDA Warning Letters

FDA Doc/cGMP

Pharm/Biotech Events

Consultants

Advertiser Info

Newsletter Subscription

Web Links

Suggestions

Site Map
 
 
   

 

  FDA Links  

FDA Links -- Regulatory Information

 

 
  1. Manual of Policies and Procedures (MaPPs) 7500.1R Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)
     
  2. CDER Manual of Policies and Procedures (MaPPs) 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site (5/6/2008)
     
  3. Guidance for Industry: Comprehensive List of Guidance Documents (updated 5/1/2008)
     
  4. Guidance for Industry: New/Revised/Withdrawn List for 2008 (updated 5/1/2008)
     
  5. Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated 4/30/2008)
     
  6. Postmarketing Study Commitments (updated 4/30/2008)
     
  7. Cyber Letters (updated 4/10/2008)
     
  8. Guidance for Industry: Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document [PDF] (updated 4/8/2008)
     
  9. Manuals of Policies and Procedures (MaPPs) (updated 4/8/2008)
    1. 4631.3R Budget Execution Planning and Reporting/Program Management System Reports
    2. 4641.5 Authority to Reimburse Employees for Business Calls Made on Personal Car Phones
    3. 7700.1 Management of the Regulatory Science and Review Enhancement Committee
       
  10. Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Draft) (PDF, 4/1/2008)
     
  11. Guidance for Industry: Comprehensive List of Guidance Documents and New/Revised/Withdrawn List for 2008 (Updated 3/31/2008)
     
  12. Guidance for Industry: Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies [PDF] (3/26/2008)
     
  13. Guidance for Industry: S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use [PDF] (3/24/2008)
     
  14. Guidance for Industry: Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims [PDF] or [HTML] (3/12/2008)
     
  15. Guidance for Industry: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route [PDF] or [HTML] (3/6/2008)
     
  16. Manuals of Policies and Procedures (MaPPs) (Update, 3/4/2008)
    1. Standards for Data Management and Analytic Processes in the Office of Surveillance and Epidemiology (OSE) [PDF]
    2. Management of the PTCC Reproductive and Developmental Toxicology Subcommittee [PDF]
       
  17. Guidance for Industry: Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention [PDF] (2/29/2008)
     
  18. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions [PDF] (2/20/2008)
     
  19. Annex I: Residue on Ignition/Sulphated Ash General Chapter [PDF] (2/20/2008)
     
  20. Guidance Documents (Updated 2/1/2008)
    1. Comprehensive List of Guidance Documents (PDF)
    2. New/Revised/Withdrawn List for 2008 (PDF)
    3. New/Revised/Withdrawn List for 2007 (PDF)
       
  21. Guidance for Industry: Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2008  (PDF, Updated 1/23/2008)
     
  22. Guidance for Industry (Draft): Q8(R1) Pharmaceutical Development Revision 1 [PDF] (1/10/2008)
     
  23. CDER Manual of Policies and Procedures (MaPPs) (updated 1/9/2008)
    1. Time-Off Incentive Award (Revised)
    2. FWAP (Flexiplace and Work at Home (Revised)
    3. Clinical Hold/Refusal-to-File Committee (New)
       
  24. Guidance for Industry: Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) (Posted 12/14/2007)
    1. Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter [PDF]
    2. Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter [PDF]
       
  25. Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 12/5/2007)
     
  26. Guidance for Industry: New/Revised/Withdrawn List for 2007 (PDF, updated 12/5/2007)
     
  27. Manual of Policies and Procedures (MaPP) Gift Certificates/Gift Cards 4636.1R (11/26/2007)
     
  28. Guidance for Industry: Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention [PDF] (11/21/2007)
     
  29. Manual of Policies and Procedures (MaPP) Accreditation - Continuing Education [PDF] (Update 11/19/2007)
     
  30. Manuals of Policies and Procedures (MaPPs) (updated 11/16/2007)
    1. Acceptability of Standards From Alternative Compendia [PDF]
    2. Classifying Resubmissions of Original NDAs, BLAs, and Efficiacy Supplements in Response to Action Letters [PDF]
       
  31. Guidance for Industry: Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment [PDF] or [HTML] (11/8/2007)
     
  32. Guidance for Industry: Comprehensive List of Guidance Documents [PDF] (Updated 11/5/2007)
     
  33. Guidance for Industry: New/Revised/Withdrawn List for 2007 [PDF] (Updated 11/5/2007)
     
  34. Guidance for Industry: Role of HIV Resistance Testing in Antiretroviral Drug Development [PDF] (10/30/2007)
     
  35. Guidance for Industry: Acute Bacterial Sinusitis: Developing Drugs for Treatment [PDF] (10/29/2007)
     
  36. Manual of Policies and Procedures (MaPPs) Preparation of Purchase/Service/Stock Requisitions in iProcurement 4631.2R (updated 10/19/2007)
     
  37. Manual of Policies and Procedures (MaPPs) Interdisciplinary Review Team for QT Studies 6020.14 (updated 10/19/2007)
     
  38. Manual of Policies and Procedures (MaPPs) Management of CDER Pharmacology/Toxicology Coordinating Committee 7400.1R (updated 10/19/2007)
     
  39. Guidance for Industry: The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) [PDF] or [HTML] (Updated 10/18/2007)
     
  40. Guidance for Industry: Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval [PDF] or [HTML] (10/12/2007)
     
  41. Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed without an Approved Application [PDF] (10/11/2007)
     
  42. Cyber Letters (updated 10/5/2007)
     
  43. Guidance for Industry: Comprehensive List of Guidance Documents (10/2/2007)
     
  44. Guidance for Industry: New/Revised/Withdrawn List for 2007 (10/2/2007)
     
  45. Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 9/18/2007)
     
  46. Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated 8/28/2007)
     
  47. Guidance for Industry: Pharmacogenomic Data Submissions — Companion Guidance [PDF] (updated 8/28/2007)
     
    48.
  48. Manuals of Policies and Procedures (MaPP) 6050.1R Refusal to Accept Application for Filing From Applicants in Arrears (updated 8/21/2007)
     
    49.
  49. Guidance for Industry: Comprehensive List of Guidance Documents (Updated 8/2/2007)
     
  50. Guidance for Industry: New/Revised/Withdrawn List for 2007 (Updated 8/2/2007)
     
    51.
  51. Manual of Policies and Procedures (MaPP) 6020.3R Priority Review Policy (7/18/2007)
     
    52.
  52. Manual of Policies and Procedures (MaPP) Procedures for Post-Approval Commitment Tracking in the Office of Generic Drugs [5200.11] (7/16/07)
     
  53. Manual of Policies and Procedures (MaPP) Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products [6020.5R] (7/16/07)
     
    54.
  54. Guidance for Industry: Q10 Pharmaceutical Quality System [PDF] (Updated 7/12/2007)
     
  55. Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information [PDF]  (7/6/2007)
     
  56. Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [HTML] or [PDF] (updated 7/2/2007)
     
  57. Guidance for Industry: Comprehensive List of Guidance Documents (PDF, updated 7/2/2007)
     
  58. Guidance for Industry: New/Revised/Withdrawn List for 2007 (PDF, updated 7/2/2007)
     
    59.
  59. Cyber Letters (updated 6/15/2007)
     
    60.
  60. Guidance for Industry: Protecting the Rights, Safety, and Welfare of Study Subjects- Supervisory Responsibilities of Investigators [PDF]  (6/7/2007)
     
  61. Manuals of Policies and Procedures (MaPPs) (updated 6/7/2007) :
    1. Alternate Work Schedules for the Office of Training and Communications [PDF]
    2. Flexible Workplace Arrangements Program for the Office of Training and Communications [PDF]
    3. Guide to the Orientation Program in the Center for Drug Evaluation and Research [PDF]
    4. Guide to Assigning Mail Codes in CDER [PDF]
       
    62.
  62. PDUFA IV: Recommendations Transmitted to Congress (PDF, 6/7/2007)
     
  63. Draft Guidance for Industry: Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis (PDF, 6/6/2007)
     
  64. Draft Guidance for Industry: Individual Product Bioequivalence Recommendations (PDF, 5/30/2007)
    1. List of Product Bioequivalence Recommendations
       
  65. Guidance for Industry: Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information [PDF]  (5/15/2007)
     
  66. Manuals of Policies and Procedures (MAPPS) (Updated 5/4/2007)
    1. 4642.1R Policies and Procedures for Organizational Changes
    2. 4657-0R CDER's Time, Attendance, and Leave Recording Policy
    3. 4657.6R Granting Excused Absence (Originator: Division of Management Services, OM)
    4. 4657.11R Religious Compensatory Time
    5. 6020.2R Applications for Parenteral Products in Plastic Immediate Containers
       
    67.
  67. Guidance for Industry: Testing of Glycerin for Diethylene Glycol [HTML] or [PDF] (Updated 5/1/2007)
     
  68. Guidance for Industry: Comprehensive List of Guidance Documents  (PDF, updated 5/1/2007)
     
  69. New/Revised/Withdrawn List for 2007 (PDF, updated 5/1/2007)
     
    70.
  70. Guidance for Industry: Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products [PDF] (4/6/2007)
     
  71. Guidance for Industry: Orally Disintegrating Tablets [PDF] (4/6/2007)
     
  72. Guidance for Industry: Comprehensive List of Guidance Documents (4/6/2007)
     
  73. Guidance for Industry: New/Revised/Withdrawn List for 2007 (4/6/2007)
     
    74.
  74. Bioresearch Monitoring Information System (BMIS) File (4/4/2007)
     
  75. Guidance for Industry and Review Staff : Target Product Profile -- A Strategic Development Process Tool [PDF] or [HTML] (3/29/2007)
     
  76. Cyber Letters (updated 3/27/2007)
     
  77. Guidance for Industry and FDA Staff: Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees [PDF]  (3/23/2007)
     
    78.
  78. Guidance Agenda: Guidances CDER is Planning to Develop During Calendar Year 2007 (updated 3/19/2007)
     
  79. Guidance for Industry: Indexing Structured Product Labeling [PDF] or [HTML] (3/13/2007)
     
  80. CDER Data Standards Manual: Countries, Dependencies, and Areas of Special Sovereignty Monograph (updated 3/9/2007)
     

 

Hit Counter
     
[ Outsourcing Guide ] [ Cont. Education ] [ Software/Reports ] [ Training Courses ]
[ Web Seminars ] [ Jobs ] [ Consultants ] [ Buyer's Guide ] [ Advertiser Info ]

[ Home ] [ Pharm Patents / Licensing ] [ Pharm News ] [ Federal Register ]
[ Pharm Stocks ] [ FDA Links ] [ FDA Warning Letters ] [ FDA Doc/cGMP ]
[ Pharm/Biotech Events ] [ Newsletter Subscription ] [ Web Links ] [ Suggestions ]
[ Site Map ]