Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway-Reference-Cited by-同舟云学术

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway

Published:2019-01 Issue:1 Volume:24 Page:46-56
ISSN:1359-6446
Container-title:Drug Discovery Today
language:en
Short-container-title:Drug Discovery Today

Author:

Salminen William F.,Wiles Marc E.^ORCID,Stevens Ruth E.^ORCID

Funder

NDA approval

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference27 articles.

1. Federal Food, Drug and Cosmetic Act (1938) Pub. L. No. 75-717, 52 Stat. 1040. Available at: http://catalog.archives.gov/id/299847

2. United States (2018) 21 Code of Federal Regulations (CFR) § 314.94. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.94

3. United States (2018) 21 Code of Federal Regulations (CFR) §§ 312, 314. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312 and https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314

4. United States (2018) 21 Code of Federal Regulations (CFR) § 314.54. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.54

5. United States (2018) 21 Code of Federal Regulations (CFR) § 314.50. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.50.

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