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  FDA Links  

FDA Links -- Regulatory Information

 

 
  1. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Updated: 9/2/2010): 
    1. Annex 11 Capillary Electrophoresis General Chapter
       
    2.
  2. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (Updated: 9/1/2010):
    1. Annex 12 Analytical Sieving General Chapter (PDF - 88KB)
       
    3.
  3. Guidance for Industry: Individual Product Bioequivalence Recommendations (26 Newly Added Recommendations; 10 Revised Recommendations) (Updated: 8/30/2010)
     
  4. Guidance for Industry: Acute Bacterial Skin and Skin Structure Infections:  Developing Drugs for Treatment (PDF - 516kb) (Updated: 8/26/2010)
     
  5. Guidance for Industry:  Organ-Specific Warnings:  Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide (PDF - 177KB) (updated 8/17/2010)
     
  6. SOPP 8116: Using Electronic Signatures for Investigational and Marketing Regulatory Document Concurrence/Signoff (Updated: 8/12/2010)
     
  7. Guidance for Industry (Updated: 8/4/2010):
    1. Comprehensive List of Guidance Documents (PDF - 740KB)
    2. New/Revised Withdrawn List of Guidances for 2010 (PDF - 80KB)
       
    8.
  8. Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products (PDF - 148KB) (8/3/2010)
     
  9. Postmarket Requirements and Commitments (8/3/2010)
     
    10.
  10. Guidance For Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 417KB) (7/30/2010)
     
  11. ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents (updated 7/19/2010)
    1. Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents
       
    12.
  12. Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports (PDF - 109KB) (updated 6/24/2010)
     
    13.
  13. Guidance for Industry (Updated 6/21/2010):
    1. Systemic Lupus Erythematosus — Developing Medical Products for Treatment (PDF - 168KB)
    2. Lupus Nephritis Caused By Systemic Lupus Erythematosus — Developing Medical Products for Treatment (PDF - 130 KB)
       
    14.
  14. Manual of Policies and Procedures (MaPPs) 5100.5 (PDF - 144KB) An Integrated Genomics, Pharmacometrics, and Clinical Pharmacology Review Process (updated 6/16/2010)
     
    15.
  15. Guidance for Industry: Bioequivalence Recommendations for Specific Products (PDF- 81KB) (updated 6/10/2010)
     
  16. Manual of Policies and Procedures (MaPP) 5015.9 Reporting Format for Nanotechnology-Related Information in CMC Review (6/3/2010)
     
  17. Guidance for Industry: 20 newly added Bioequivalence Guidances (updated 5/21/2010)
     
  18. Regulatory Submissions in Electronic Format for Biologic Products (Posted: 5/10/2010)
     
    19.
  19. Guidance for Industry: International Conference on Harmonisation-Quality: Q8, Q9, and Q10 Questions and Answers (5/5/2010)
     
  20. Guidance for Industry: Newly Added Bioequivalence Guidances (updated 4/23/2010)
     
  21. Guidance for Industry:  Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (updated 4/9/2010)
    1. Annex 10: Polyacrylamide Gel Electrophoresis General Chapter (PDF - 84 KB)
       
    22.
  22. Guidance for Industry:Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (updated 4/2/2010)
    1. Annex 7:Dissolution Test General Chapter (PDF - 93 KB)
    2. Annex 9: Tablet Friability General Chapter (PDF - 84 KB)
       
  23. Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages (3/26/2010)
     
    24.
  24. Guidance for Industry (updated 3/22/2010):
    1. Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 143 KB)
    2. Irritable Bowel Syndrome -- Clinical Evaluation of Products for Treatment (PDF - 221 KB)
       
  25. Manual of Policies and Procedures (MaPPs) 5015.5 CMC Reviews of Type III DMF's for Packaging Materials (PDF - 75 KB) (3/19/2010)
     
  26. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 151 KB) (updated 3/17/2010)
     
  27. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 151 KB) (updated 3/17/2010)
     
  28. Guidance for Industry:  S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB) (3/5/2010)
     
  29. Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 565 KB) (updated 2/26/2010):
     
  30. Guidance for Industry (updated 2/25/2010):
    1. Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 424 KB)
    2. Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes (PDF - 69 KB)
    3. Individual Bioequivalence Guidances Newly Added Recommendations
       
  31. Guidance for Industry:  Individual Product Bioequivalence Recommendations (updated 2/12/2010)
     
  32. Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306 KB) (updated 2/5/2010)
     
  33. Guidance for Industry (updated 1/26/2010):
    1. Assessment of Abuse Potential of Drugs (PDF - 138 KB)
    2. The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)(PDF - 38 KB)
       
  34. Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF - 295 KB) (1/20/2010)
     
  35. Guidance to Pharmacies: Compounding Tamiflu Oral Suspension in Advance to Provide for Multiple Prescriptions (PDF - 114KB) (1/11/2010)
     
  36. Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 47KB) (1/7/2010)
     
  37. Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 858KB)  (Updated: 12/28/2009)
     
  38. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (updated 12/22/2009)
    1. Annex 5: Disintegration Test General Chapter (PDF - 32 KB)
    2. Annex 8: Sterility Test General Chapter (PDF - 32 KB)
       
  39. Guidance for Industry: 35 Newly added Bioequivalence Recommendations (updated 12/18/2009)
     
  40. Guidance for Industry: (Updated 12/16/2009)
    1. Addendum to ICH S6: Preclinical Safety Evaluation of  Biotechnology -Derived Pharmaceuticals S6(R1)(PDF - 160 KB) 
    2. Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
      1. Annex 11: Capillary Electrophoresis (PDF - 90 KB)
        General Chapter
      2. Annex 12: Analytical Sieving General Chapter (PDF - 313 KB)
         
  41. Guidance for Industry: PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 KB)  (Updated 12/9/2009)
     
  42. Guidance for Industry:  Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF -295 KB) (updated 12/8/2009)
     
  43. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161 KB) (12/3/2009)
     
  44. Guidance for Industry: 
    1. Comprehensive List of Guidance Documents (PDF - 698 KB)  (updated 12/1/2009)

    2. New/Revised/Withdrawn List for 2009 (PDF - 116 KB)  (12/1/2009)
       

  45. Guidance for Industry: Newly added Individual Product Bioequivalence Recommendations (updated 11/30/2009)
     
  46. Guidance for Industry:  Residual Solvents in Drug Products Marketed in the United States (PDF - 52 KB) (11/24/2009)
     
  47. Guidance for Industry: Q8(R2) Pharmaceutical Development (11/20/2009)
     
  48. Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (PDF - 79KB) (Posted: 11/13/2009)
     
  49. Guidance for Industry:  E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (Updated: 11/9/2009)
     
  50. Guidance for Industry:  Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB) (11/4/2009)
     
  51. Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions (11/2/2009)
     
  52. Draft Guidance for Industry: SPL Standard for Content of Labeling Technical Qs & As (PDF - 56KB) (10/27/2009)
     
  53. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB) (Updated: 10/23/2009)
     
  54. Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 (PDF - 737KB) (Posted: 10/21/2009)
     
  55. Guidance for Industry:  Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB) (10/16/2009)
     
  56. Guidance for Industry:  Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (updated 10/2/2009)
     
  57. Guidance for Industry:  Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (updated 9/30/2009)
     
  58. Guidance for Industry: End-of-Phase 2A Meetings (9/18/2009)
     
  59. Manual of Policies and Procedures (MaPP) 6720.2 Procedures for Handling Requests for Proprietary Name Review (9/17/2009)
     
  60. Guidance for Industry:  Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (9/16/2009)
     

    

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