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HE 20.4702:EX 2/3
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Guidance for industry 180-day generic drug exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act. |
1 |
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HE 20.4702:F 26
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Guidance for industry fast track drug development programs, designation, development and application review. |
1 |
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HE 20.4702:F 47
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Guidance for industry drug master files for bulk antibiotic drug substances. |
1 |
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HE 20.4702:F 49
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Guidance for industry financial disclosure by clinical investigators. |
1 |
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HE 20.4702:F 73
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Guidance for industry food-effect bioavailability and fed bioequivalence studies. |
1 |
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HE 20.4702:G 28
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Frecuentes preguntas acerca de las drogas genéricas |
1 |
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HE 20.4702:G 28/2
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S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use |
1 |
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HE 20.4702:G 28/3/DRAFT
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E 16 genomic biomarkers related to drug response context, structure, and format of qualification submissions. |
1 |
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HE 20.4702:G 28/4
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Guidance for industry S2B genotoxicity, a standard battery for genotoxicity testing of pharmaceuticals. |
1 |
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HE 20.4702:G 28/DRAFT
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Guidance for industry genotoxic and carcinogenic impurities in drug substances and products, recommended approaches. |
1 |
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HE 20.4702:G 52
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Guidance for industry testing of glycerin for diethylene glycol. |
1 |
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HE 20.4702:G 59
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Good laboratory practice regulations, questions and answers |
1 |
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HE 20.4702:G 76
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Guidance for industry granularity document : annex to M4, organization of the CTD. |
1 |
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HE 20.4702:H 19
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Guidance for industry handling and retention of BA and BE testing samples. |
1 |
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HE 20.4702:H 35/2/SPAN
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La pérdida del oído, los audífonos una charla franca con la FDA. |
1 |
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HE 20.4702:H 36/DRAFT
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Guidance for industry "help-seeking" and other disease awareness communications by or on behalf of drug and device firms. |
1 |
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HE 20.4702:H 43
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Dieta para un corazón saludable |
1 |
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HE 20.4702:H 79
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Guidance for hospitals, nursing homes and other health care facilities |
1 |
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HE 20.4702:H 99
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Guidance for industry hypertension indication, drug labeling for cardiovascular outcome claims. |
1 |
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HE 20.4702:ID 2/DRAFT
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Guidance for industry incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting. |
1 |
