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  FDA Links  

FDA Links -- Regulatory Information

 

 
  1. Guidance for Industry:  S9 Nonclinical Evaluation for Anticancer Pharmaceuticals (PDF - 170 KB) (3/5/2010)
     
  2. Guidance for Industry: Non-Inferiority Clinical Trials (PDF - 565 KB) (updated 2/26/2010):
     
  3. 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
       
  4. Guidance for Industry:  Individual Product Bioequivalence Recommendations (updated 2/12/2010)
     
  5. Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306 KB) (updated 2/5/2010)
     
  6. 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)
       
  7. 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)
     
  8. Guidance to Pharmacies: Compounding Tamiflu Oral Suspension in Advance to Provide for Multiple Prescriptions (PDF - 114KB) (1/11/2010)
     
  9. Guidance for Industry: Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 47KB) (1/7/2010)
     
  10. 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)
     
  11. 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)
       
  12. Guidance for Industry: 35 Newly added Bioequivalence Recommendations (updated 12/18/2009)
     
  13. 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)
         
  14. Guidance for Industry: PET Drug Products - Current Good Manufacturing Practice (CGMP) (PDF - 399 KB)  (Updated 12/9/2009)
     
  15. Guidance for Industry:  Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF -295 KB) (updated 12/8/2009)
     
  16. Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161 KB) (12/3/2009)
     
  17. 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)
       

  18. Guidance for Industry: Newly added Individual Product Bioequivalence Recommendations (updated 11/30/2009)
     
  19. Guidance for Industry:  Residual Solvents in Drug Products Marketed in the United States (PDF - 52 KB) (11/24/2009)
     
  20. Guidance for Industry: Q8(R2) Pharmaceutical Development (11/20/2009)
     
  21. 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)
     
  22. Guidance for Industry:  E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers (Updated: 11/9/2009)
     
  23. Guidance for Industry:  Dosage Delivery Devices for OTC Liquid Drug Products (PDF -93 KB) (11/4/2009)
     
  24. Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions (11/2/2009)
     
  25. Draft Guidance for Industry: SPL Standard for Content of Labeling Technical Qs & As (PDF - 56KB) (10/27/2009)
     
  26. Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (PDF - 163 KB) (Updated: 10/23/2009)
     
  27. 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)
     
  28. 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)
     
  29. Guidance for Industry:  Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (updated 10/2/2009)
     
  30. Guidance for Industry:  Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (updated 9/30/2009)
     
  31. Guidance for Industry: End-of-Phase 2A Meetings (9/18/2009)
     
  32. Manual of Policies and Procedures (MaPP) 6720.2 Procedures for Handling Requests for Proprietary Name Review (9/17/2009)
     
  33. Guidance for Industry:  Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (9/16/2009)
     
  34. Guidance for Industry: Newly finalized Bioequivalence Guidance: Tacrolimus (9/1/2009)
     
  35. Guidance for Industry: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act:  Questions and Answers (8/31/2009)
     
  36. Guidance For Industry: 21 Newly Added Individual Bioequivalence Recommendations (8/18/2009)
     
  37. Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination (Posted: 8/6/2009)
     
  38. Guidance for Industry: E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (7/30/2009)
     
  39. Guidance for Industry:  Drug-Induced Liver Injury: Premarketing Clinical Evaluation (7/29/2009)
     
  40. Guidance for Industry: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act (7/15/2009)
     
  41. Guidance for Industry: ANDAs: Impurities in Drug Substances (7/15/2009)
     
  42. Guidance for Industry: Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (7/13/2009)
     
  43. Guidance for Industry: Incorporation of  Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (7/13/2009)
     
  44. Guidance for Industry: Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (6/26/2009)
     
  45. Manual of Policies and Procedures (MaPP) Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue (Updated 6/9/2009)
     
  46. Guidance for Industry: Q8(R1) Pharmaceutical Development Revision 1 (Updated 6/8/2009)
     
  47. Guidance for Industry:  Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events (Updated 6/8/2009)
     
  48. Guidance for Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application  (updated 6/2/09)
     
  49. Guidance for Industry (updated 5/28/2009):
    1. Newly Added Bioequivalence Recommendations 21 Newly Added Recommendations.
    2. Guidance for Industry: Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing [PDF]
       
  50. Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion [PDF] (updated 5/26/2009)
     
  51. Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants [PDF] (5/19/2009)
     
  52. Manual of Policies and Procedures (MaPP) 7700.2 Review and Conduct of Human Subject Research (5/19/2009)
     
  53. Guidance for Industry: Labeling OTC Human Drug Products; Small Entity Compliance Guide [PDF] (5/12/2009)
     
  54. Guidance for Industry (Updated: 5/7/2009):
    1. Comprehensive List of Guidance Documents (PDF)
    2. New Revised/Withdrawn List for 2009 (PDF)
       
  55. Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products PDF (4/30/2009)
     
  56. Manual of Policies and Procedures (MaPP) 5100.4 Scientific Interest Groups: Criteria and Policies (updated 4/28/2009)
     
  57. Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document [PDF] (4/20/2009)
     
  58. Guidance for Industry: Submission of Summary Bioequivalence Data for ANDAs [PDF] (4/16/2009)
     
  59. Guidance for Industry (updated 4/7/2009) :
    1. Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions
      1. Annex 4A: Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter [PDF]
      2. Annex 4B: Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms General Chapter [PDF]
      3. Annex 4C: Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter [PDF]
    2. Q10 Pharmaceutical Quality System [PDF]
       
  60. Manual of Policies and Procedures (MaPP): 5210.3R Productivity Documentation in the Division of Bioequivalence (Updated 4/6/2009)

    

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