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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.