Search

1. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, October 2019

Subject(s):

Drug Approval -- economics
Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

2. Citizen petitions and petitions for stay of action subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2019

Subject(s):

Drug Approval -- legislation & jurisprudence
Investigational New Drug Application -- legislation & jurisprudence
Public Health -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

3. FDA oversight

Author(s):

White, Robert S., (Compliance attorney and member of the Oklahoma Bar), author

Publication:

[Toronto, Ontario] : Thomson Reuters, 19-December-2022

Subject(s):

Drug Approval -- legislation & jurisprudence
Government Regulation
Legislation, Drug
Drug-Related Side Effects and Adverse Reactions
Illicit Drugs
United States
United States. Food and Drug Administration

4. Strengthening the accelerated approval pathway: an analysis of potential policy reforms and their impact on uncertainty, access, innovation, and costs

Author(s):

Kaltenboeck, Anna, author
Mehlman, Amanda, author
Pearson, Steven D., author

Publication:

[Boston, Massachusetts] : Institute for Clinical and Economic Review, April 26, 2021

Subject(s):

Drug Approval -- economics
Drug Approval -- legislation & jurisprudence
United States