Search Results - U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research,
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1
CDER ... report to the nation : improving public health through human drugs /
Published 1998“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Serial -
2
CDER ... report to the nation /
Published 1998“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Serial -
3
Report to industry.
Published 1997“…U.S. Dept. of Health and Human Services, Food and …”
Government Document Serial -
4
E 16 genomic biomarkers related to drug response context, structure, and format of qualification submissions.
Published 2009“…[U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
5
Guidance for industry bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action.
Published 2003“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
6
Guidance for industry ANDAs, impurities in drug substances.
Published 2009“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
7
Guidance for industry submission of summary bioequivalence data for ANDAs.
Published 2009“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
8
Guidance for industry nasal spray and inhalation solution, suspension, and spray drug products : chemistry, manufacturing, and controls documentation.
Published 2002“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
9
Guidance for industry SUPAC-IR/MR : immediate release and modified release solid oral dosage forms : manufacturing equipment addendum.
Published 1999“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
10
Guidance for industry handling and retention of BA and BE testing samples.
Published 2004“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
11
Guidance for industry liposome drug products, chemistry, manufacturing, and controls; human pharmacokinetics and bioavailablity; and labeling documentation.
Published 2002“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
12
Guidance for industry expiration dating and stability testing of solid oral dosage form drugs containing iron.
Published 1997“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
13
Guidance for industry botanical drug products.
Published 2004“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
14
Structure and content of clinical study reports
Published 1996“…[U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic Conference Proceeding eBook -
15
Guidance for industry M4Q, the CTD, quality.
Published 2001“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic Conference Proceeding eBook -
16
Guidance for industry orally disintegrating tablets.
Published 2008“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
17
Guidance for industry photosafety testing.
Published 2003“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
18
Guidance for industry influenza, developing drugs for treatment and/or prophylaxis.
Published 2009“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook -
19
Center for Drug Evaluation and Research update.
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Government Document Serial -
20
Guidance for industry investigating out-of-specification test results (OOS) for pharmaceutical production.
Published 2006“…U.S. Dept. of Health and Human Services, Food and …”
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Government Document Electronic eBook