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  FDA Links  

FDA Links -- Regulatory Information

 

  1. Guidance for Industry:  FDA Regulation of PET Drug Products Questions and Answers (PDF - 1040KB) (updated 2/2/2012)
     
    2.
  2. Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (PDF - 153KB) (updated 1/24/2012)
     
  3. Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage (PDF - 157KB) (Posted: 1/18/2012)
     
  4. Guidance for Industry (updated 1/4/2012):
    1. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
    2. Comprehensive List (Research List) of CDER Guidance Documents (PDF - 650KB)
    3. New, Revised, Withdrawn List of CDER Guidance Documents (PDF -120KB)
       
    5.
  5. Guidance for Industry: Use of Histology in Biomarker Qualification Studies (PDF - 298KB) (12/29/2011)
     
  6. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirement for Manufacturers of Human Cells, Tissues, adn Cellular and Tissue-Based Products (HCT/Ps) (PDF - 371KB) (Posted:12/28/2011)
     
  7. Guidance for Industry:  Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF - 258KB) (12/27/2011)
     
  8. Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF - 79KB) (Posted:12/13/2011)
     
  9. Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (PDF - 57KB) (Posted:12/8/2011)
     
  10. Guidance for Industry: M2: eCTD Specification Questions & Answers and Change Requests Companion Document (excel) (Posted:12/7/2011)
     
  11. Guidance for Industry: Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 97KB) (Updated:12/1/2011)
     
  12. Guidance for Industry: Bioequivalence Recommendations for Specific Products (updated 11/29/2011) 
     
  13. Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components, including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus (PDF - 168KB) (Posted:11/29/2011)
     
    14.
  14. Guidance for Industry: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals (PDF - 137KB) (11/25/2011)
     
  15. Guidance for Industry:  Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)(PDF - 92KB) (11/17/2011)
     
  16. Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines (PDF - 75KB) (Posted: 11/7/2011)
     
  17. Guidance for Industry: Bioequivalence Recommendations for Specific Products (Updated 10/27/2011)
     
  18. Draft Guidance for Industry: Implementation of Acceptable Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components (PDF - 62KB) (Posted: 10/24/2011)
     
  19. Guidance for Industry  (updated 10/19/2011): 
    1. E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
       
  20. Guidance for Industry (Updated:10/11/2011):
    1. Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 74KB)14
    2. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB)
       
  21. Guidance for Industry: Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs (PDF - 134KB) (updated 9/29/2011)
     
  22. Guidance for Industry: Time and Extent Applications for Nonprescription Drug Products (PDF - 242KB) (updated 9/28/2011)
     
  23. Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 288KB) (9/26/2011)
     
  24. Guidance for Industry:  Reproductive and Developmental Toxicities -- Integrating Study Results to Assess Concerns (PDF - 392KB)  (Updated: 9/22/2011)
     
  25. FDA Issues Revised Guidance on Marketed Unapproved Drugs (Updated: 9/19/2011)
    1. Guidance for Industry:  Marketed Unapproved Drugs – Compliance Policy Guide (PDF - 165KB)
    2. Notice to Industry
       
  26. Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products  (PDF - 152KB) (Updated: 9/16/2011)
     
  27. Guidance for Industr (Updated 9/6/2011):
    1. Comprehensive List of Guidance Documents (PDF - 559KB)
    2. New/Revised Withdrawn List for 2011 (PDF - 97KB)
       
  28. Guidance for Industry (8/29/2011): 
    1. Tablet Scoring:Nomenclature, Labeling, and Data for Evaluation (PDF - 99KB)
    2. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (PDF - 150KB)
       
  29. Draft Guidance for Industry:  Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF - 194KB) (updated 8/23/2011)
     
  30. Guidance for Industry (Final): E2F Development Safety Update Report (PDF - 273KB) (8/22/2011)
     
  31. Draft Guidance for Industry: Standards for Clinical Trial Imaging Endpoints (PDF - 266KB) (8/18/2011)
     
  32. Guidance for Industry: Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB) (8/16/2011)
     
  33. Guidance for Industry:  ICH E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF - 112KB) (Updated: 8/10/2011)
     
  34. Guidance for Industry: Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments (Posted: 8/5/2011)
     
  35. Guidance for Industry: PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (PDF - 229KB) (8/4/2011)
     
  36. DRAFT Guidance for Industry: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma (PDF - 57KB) (7/22/2011)
     
  37. Guidance for Industry  (updated 7/19/2011):
    1. Comprehensive List of Guidance Documents (PDF - 569KB)
    2. New/Revised Withdrawn List for 2011 (PDF - 76KB)
       
  38. Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices (updated 7/12/2011)
     
  39. Guidance for Industry: Q11 Development and Manufacture of Drug Substances (PDF - 758) (updated 6/28/2011)
     
  40. Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 7(R2) Dissolution Test General Chapter (PDF - 102KB) (updated 6/23/2011)
     
  41. Guidance for Industry: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB) (updated 6/21/2011)
     
  42. Guidance for Industry: Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (PDF - 223KB) (6/16/2011)
     
  43. Guidance for Industry: Enforcement Policy -- OTC  Sunscreen Drug Products Marketed Without an Approved Application (PDF - 133KB) (updated 6/14/2011)
     
  44. Guidance for Industry: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 115KB) (Updated: 6/8/2011)
     
  45. Guidance for Industry: Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB) (6/6/2011)
     
  46. Guidance for Industry: Financial Disclosure by Clinical Investigators (5/25/2011)
     
  47. Guidance for Industry (updated 5/9/11):
    1. New/Revised Withdrawn List for 2011 (PDF - 55KB) 
    2. New/Revised/Withdrawn List for 2010 (PDF - 120KB)
       
  48. Guidance for Industry:  Submission of Summary Bioequivalence Data for ANDAs (PDF - 138 KB) (updated 5/5/2011)
     
  49. Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF-595KB) (5/4/2011)
     
  50. Guidance for Industry: Individual Product Bioequivalence Recommendations (updated 4/29/2011)
     
  51. Guidance for Industry (4/12/2011):
    1. Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (PDF - 129KB
    2. Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF - 418KB)
       
  52. Guidance for Industry: Individual Product Bioequivalence Recommendations Newly Added Recommendations and Revisions (Updated: 3/31/2011)
     
  53. Guidance for Industry: Postmarketing Studies and Clinical Trials -- Implementation of Section 505(0)(3) of the Federal Food, Drug, and Cosmetic Act (PDF - 277 KB) (Updated: 3/31/2011)
     
  54. Guidance for Industry: Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay (Updated: 3/28/2011)
     
  55. Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container (Updated: 3/28/2011)
     
  56. Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle (Updated: 3/28/2011)
     
  57. Guidance for Industry (Updated 3/14/2011):
    1. Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 147KB)
    2. Non-Penicillin Beta-Lactam Risk Assessment:  A CGMP Framework (PDF - 116KB)
    3. Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 82KB)
       
  58. Guidance for Industry: User Fee Waivers, Reductions, and Refunds for Drug and Biological Products (PDF - 256KB) (3/11/2011)
     
  59. Guidance for Industry: Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (PDF - 96KB) (2/25/2011)
     
  60. Guidance for Industry: Clinical Pharmacogenomics:  Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB) (2/17/2011)

    

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