Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Section Content Menu
Skip to Common Links
U.S. Food & Drug Administration
A to Z Index
Follow FDA
FDA Voice Blog
Enter Search terms
Most Popular Searches
Home
Food
Drugs
Medical Devices
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Radiation-Emitting Products
Tobacco Products
Drugs
Home
Drugs
Guidance, Compliance & Regulatory Information
Guidances (Drugs)
Section Contents Menu
Guidance, Compliance & Regulatory Information
Guidances (Drugs)
Advertising
Bioequivalence Recommendations for Specific Products
Biopharmaceutics
Biosimilarity
CMC - Microbiology (Chemistry, Manufacturing, and Controls)
Chemistry, Manufacturing, and Controls (CMC)
Clinical / Antimicrobial
Clinical / Medical
Clinical Pharmacology
Combination Products
Concept Papers
Current Good Manufacturing Practices (CGMPs)/Compliance
Drug Safety
Electronic Submissions
FDAAA (Food and Drug Administration Amendments Act)
Generics
Good Review Practices
Industry Letters
International Conference on Harmonisation - Efficacy
International Conference on Harmonisation - Joint Safety/Efficacy (Multidisciplinary)
International Conference on Harmonisation - Quality
International Conference on Harmonisation - Safety
Investigational New Drug Applications
Labeling
Microbiology
Modernization Act
Over-the-Counter
Pharm / Tox
Procedural
Small Entity Compliance Guides
User Fees
-
Industry Letters
Below is a sortable listing of Industry Letters Guidances:
-
Category
Title
Type
Date
Industry Letters
Continuation of a series of letters communicating interim and informal generic drug policy and guidance. Availability of Policy and Procedure Guides, and further operational changes to the generic drug review program
(PDF - 611KB)
Final Guidance
03/02/98
Industry Letters
Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required
(PDF - 243KB)
Final Guidance
03/02/98
Industry Letters
Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I
(PDF - 839KB)
Final Guidance
03/02/98
Industry Letters
Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance
(PDF - 644KB)
Final Guidance
03/02/98
Industry Letters
Implementation Plan USP injection nomenclature
(PDF - 247KB)
Final Guidance
03/02/98
Industry Letters
Seventh of a series of letters about the Act providing guidance on the "130-day exclusivity" provision of section 505(j)(4)(B)(iv) of the FD&C
(PDF - 730KB)
Final Guidance
03/02/98
Industry Letters
Sixth of a series of informal notice letters about the Act discussing 3-and 5-year exclusivity provisions of sections 505(c)(3)(D) and 505(j)(4)(D) of the FD&C Act
(PDF - 538KB)
Final Guidance
03/02/98
Industry Letters
Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)
(PDF - 740KB)
Final Guidance
03/02/98
Industry Letters
Third of a series of letters regarding the implementation of the Act
(PDF - 393KB)
Final Guidance
03/02/98
Industry Letters
Year 2000 Letter from Dr. Janet Woodcock
Final Guidance
10/19/98
-
-
-