| Title and Format |
Type |
Issue Date |
|
180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 162 KB)
|
Final |
7/2003 |
| Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (PDF - 14 KB) |
Final |
12/2000 |
| ANDAs: Impurities in Drug Products (PDF - 104 KB) |
Draft |
8/26/2005 |
| ANDAs: Impurities in Drug Substances (PDF - 136 KB) |
Final |
7/15/2009 |
| ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information (PDF - 125 KB) |
Final |
7/6/2007 |
| Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (PDF - 25 KB) |
Final |
3/2000 |
| Handling and Retention of Bioavailability and Bioequivalence Testing Samples (PDF - 166 KB) |
Final |
5/25/2004 |
Individual Product Bioequivalence Recommendations (PDF - 45 KB)
List of Product Bioequivalence Recommendations |
Draft |
5/30/2007 |
| 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 - 194 KB) |
Final |
8/1995 |
| 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 - 274 KB) |
Final |
10/1994 |
| 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 - 1915 KB) |
Final |
4/1994 |
| Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF - 254 KB) |
Final |
7/1992 |
| Letter on the provision of new procedures and policies affecting the generic drug review process (PDF - 608 KB) |
Final |
3/1989 |
| 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 - 917 KB) |
Final |
11/1990 |
| 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 - 392 KB) |
Final |
3/1985 |
| 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 - 233 KB) |
Final |
1/1993 |
| Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908 KB) |
Final |
8/1993 |
| 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 - 57 KB) |
Draft |
10/2004 |
| Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications (PDF - 24 KB) |
Final |
12/2001 |
| Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (PDF - 48 KB) |
Final |
10/25/2005 |
| Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19 KB) |
Final |
4/26/2000 |
| Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 183 KB) |
Draft |
4/16/2009 |
| Variations in Drug Products that May Be Included in a Single ANDA (PDF - 107 KB) |
Final |
12/1998 |
