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. 1

    CDER ... report to the nation : improving public health through human drugs /

    Published 1998
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Serial
  2. 2

    CDER ... report to the nation /

    Published 1998
    “…U.S. Dept. of Health and Human Services, Food and …”
    Connect to online resource
    Latest issue only:
    Archived issues:
    Archived issues:
    Request a PDF (UCB only)
    Government Document Serial
  3. 3

    Report to industry.

    Published 1997
    “…U.S. Dept. of Health and Human Services, Food and …”
    Government Document Serial
  4. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  5. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  6. 6

    Guidance for industry ANDAs, impurities in drug substances.

    Published 2009
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  7. 7

    Guidance for industry submission of summary bioequivalence data for ANDAs.

    Published 2009
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  8. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  9. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  10. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  11. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  12. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
  13. 13

    Guidance for industry botanical drug products.

    Published 2004
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  14. 14

    Structure and content of clinical study reports

    Published 1996
    “…[U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic Conference Proceeding eBook
  15. 15

    Guidance for industry M4Q, the CTD, quality.

    Published 2001
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic Conference Proceeding eBook
  16. 16

    Guidance for industry orally disintegrating tablets.

    Published 2008
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  17. 17

    Guidance for industry photosafety testing.

    Published 2003
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  18. 18

    Guidance for industry influenza, developing drugs for treatment and/or prophylaxis.

    Published 2009
    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Electronic eBook
  19. 19

    Center for Drug Evaluation and Research update.

    “…U.S. Dept. of Health and Human Services, Food and …”
    Online Access
    Online Access
    Government Document Serial
  20. 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 …”
    Online Access
    Online Access
    Government Document Electronic eBook
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