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eBook

FDA Drug Approval: Elements and Considerations

Subjects: Drug approval--United States; Clinical trials--United StatesMEDICAL / Pharmacology

  • Abstract: The Food and Drug Administration (FDA) oversees the approval and regulation of drugs entering the U.S. ...

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Book

accelerated drug approval

  • Source: Taber's Cyclopedic Medical Dictionary, 22nd ed F.A. Davis Company, (Philadelphia, Pennsylvania), 2013.

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Book

drug approval

  • Source: Taber's Cyclopedic Medical Dictionary, 22nd ed F.A. Davis Company, (Philadelphia, Pennsylvania), 2013.

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Academic Journal

Analysis of Pediatric Drug Approval Lag in Japan.

  • Source: Therapeutic Innovation & Regulatory Science (THER INNOV REGULATORY SCI), 2021; 55(2): 336-345. (10p)

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Academic Journal

Impact of Quality by Design Development on the Review Period of New Drug Approval and Product Quality in Japan.

Subjects: PHARMACEUTICAL chemistry; PHARMACEUTICAL industry; PRODUCT recallJAPAN

  • Source: Therapeutic Innovation & Regulatory Science; Sep2020, Vol. 54 Issue 5, p1192-1198, 7p

  • Abstract: Background: For pharmaceutical products, an in-depth understanding of manufacturing processes and quality risks associated with quality by design (QbD) development enables the production of high-quality ... Copyright of Therapeutic Innovation & Regulatory Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites ...

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  • 1-10 of  103,000 results for ""DRUG approval""