Guidance for industry : 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.
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| Format: | Government Document eBook |
| Language: | English |
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Rockville, MD :
U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
[2004]
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| Online Access: | https://purl.fdlp.gov/GPO/LPS117075 |
| Item Description: | "Draft guidance." "OGD." "October 2004." Electronic resource. |
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| Physical Description: | 1 online resource (12 pages). |