Generics
|
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 162KB)
|
Final Guidance
|
07/01/03
|
Generics
|
Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (PDF - 14KB)
|
Final Guidance
|
12/01/00
|
Generics
|
ANDAs: Impurities in Drug Products (PDF - 155KB)
|
Final Guidance
|
11/26/10
|
Generics
|
ANDAs: Impurities in Drug Substances (PDF - 136KB)
|
Final Guidance
|
07/15/09
|
Generics
|
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (PDF - 125KB)
|
Final Guidance
|
07/06/07
|
Generics
|
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (PDF - 25KB)
|
Final Guidance
|
03/01/00
|
Generics
|
Handling and Retention of Bioavailability and Bioequivalence Testing Samples (PDF - 166KB)
|
Final Guidance
|
05/25/04
|
Generics
|
Individual Product Bioequivalence Recommendations for Specific Products (PDF - 80KB)
|
Final Guidance
|
06/10/10
|
Generics
|
Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past. (PDF - 194KB)
|
Final Guidance
|
08/01/95
|
Generics
|
Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (PDF - 274KB)
|
Final Guidance
|
10/01/94
|
Generics
|
Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (PDF - 1.9MB)
|
Final Guidance
|
09/01/94
|
Generics
|
Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF - 254KB)
|
Final Guidance
|
07/01/92
|
Generics
|
Letter on the provision of new procedures and policies affecting the generic drug review process (PDF - 608KB)
|
Final Guidance
|
03/01/89
|
Generics
|
Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (PDF - 917KB)
|
Final Guidance
|
11/01/90
|
Generics
|
Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (PDF - 392KB)
|
Final Guidance
|
03/01/85
|
Generics
|
Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (PDF - 233KB)
|
Final Guidance
|
01/01/93
|
Generics
|
Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908KB)
|
Final Guidance
|
08/01/93
|
Generics
|
Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 -- Questions and Answers (PDF - 57KB)
|
Draft Guidance
|
11/04/04
|
Generics
|
Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (PDF - 24KB)
|
Final Guidance
|
12/01/01
|
Generics
|
Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19KB)
|
Final Guidance
|
04/26/00
|
Generics
|
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 137KB)
|
Final Guidance
|
05/05/11
|
Generics
|
Variations in Drug Products that May Be Included in a Single ANDA (PDF - 107KB)
|
Final Guidance
|
12/01/98
|
Generics
|
Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations
|
Draft Guidance
|
08/22/12
|
Generics
|
Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers
|
Draft Guidance
|
08/22/12
|