US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development-Reference-Cited by-同舟云学术

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US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development

Published:2023-07 Issue:7 Volume:28 Page:103618
ISSN:1359-6446
Container-title:Drug Discovery Today
language:en
Short-container-title:Drug Discovery Today

Author:

Salminen William F.^ORCID,Aloba Olu,Drew Angela,Marcinowicz Agnieszka,Huang Madelyn

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference40 articles.

1. United States. Federal Food, Drug and Cosmetic Act, Pub. L. No. 75-717, 52 Stat. 1040 (“Federal Food, Drug, and Cosmetic Act”). 1938.

2. United States. 21 Code of Federal Regulations (CFR) §§ 312, 314. 2022

3. United States. 21 United States Code (USC) § 355(b)(1). 2022.

4. United States. 21 Code of Federal Regulations (CFR) § 314.50. 2022.

5. United States. 21 United States Code (USC) § 355(b)(2). 2022.

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