Search

1. REMS: FDA's application of statutory factors in determining when a REMS is necessary

Publication:

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

Subject(s):

Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

2. Medicaid: CMS needs to implement risk-based oversight of Puerto Rico’s procurement process : report to Congressional committees

Publication:

Washington, DC : United States Government Accountability Office, February 2021

Subject(s):

Fraud -- prevention & control
Government Regulation
Medicaid -- economics
Risk Evaluation and Mitigation -- legislation & jurisprudence
Puerto Rico
United States

3. Generic drug development: stakeholders’ views of risk evaluation and mitigation strategies differ : report to the Chairman, Committee on Energy and Commerce, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, October 2019

Subject(s):

Drug Industry -- legislation & jurisprudence
Drugs, Generic -- isolation & purification
Government Regulation
Risk Evaluation and Mitigation -- legislation & jurisprudence
United States
United States. Food and Drug Administration

4. FDA’s risk evaluation and mitigation strategies: uncertain effectiveness in addressing the opioid crisis

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2020

Subject(s):

Government Regulation
Opioid-Related Disorders -- economics
Risk Evaluation and Mitigation -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration