Drugs

Generics

Below is a sortable listing of Generics Guidances.

CategoryTitleTypeDate
Generics 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 138KB) Final Guidance 07/01/03
Generics Controlled Correspondence Related to Generic Drug Development (PDF - 379KB) Final Guidance 09/28/15
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 - 190KB) Final Guidance 05/25/04
Generics Individual Product Bioequivalence Recommendations for Specific Products (PDF - 80KB) Final Guidance 06/10/10
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 Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (PDF - 34KB) 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 Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision 1) (PDF - 244KB) Draft Guidance 09/10/13
Generics ANDA Submissions -- Refuse-to-Receive Standards (PDF - 206KB) Final Guidance 05/26/15
Generics ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 214KB) Draft Guidance 06/11/14
Generics ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 231KB) Draft Guidance 07/10/14
Generics ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 173KB) Draft Guidance 07/10/14
Generics ANDA Submissions — Refuse to Receive for Lack of Proper Justification of Impurity Limits (PDF - 80KB) Draft Guidance 09/16/14
Generics How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) Draft Guidance 12/04/14
Generics Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (PDF - 53KB) Draft Guidance 10/05/15
Generics; Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 432KB) Final Guidance 02/12/16
Generics General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 2.3MB) Draft Guidance 03/24/16

Page Last Updated: 03/24/2016
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