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1. Assessing user fees under the Generic Drug User Fee Amendments of 2017

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2022

Subject(s):

Drug Industry -- legislation & jurisprudence
Drugs, Generic -- economics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Business practices

Author(s):

Steiner, David J., author

Publication:

Toronto, Ontario : Thomson Reuters, 23-December-2019

Subject(s):

Commerce
Drug Industry -- legislation & jurisprudence
Equipment and Supplies
Legislation, Drug
United States

3. Business practices

Author(s):

Steiner, David J., author

Publication:

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

Subject(s):

Crime -- legislation & jurisprudence
Drug Industry -- legislation & jurisprudence
Health Care Sector -- legislation & jurisprudence
Opioid Epidemic
United States

4. Congreso Internacional de Derecho y Economia Farmaceutica

Author(s):

Congreso Internacional de Derecho y Economia Farmaceutica (1990 : Granada, Spain)

Publication:

[Grenada, Spain : Cátedra de Historia de la Farmacia y Legislación Farmacéutica, Facultad de Farmacia, Campus Universitario de la Cartuja, 1990]

Subject(s):

Legislation, Pharmacy
Drug Industry -- economics
Drug Industry -- legislation & jurisprudence
Economics, Pharmaceutical

5. Drug manufacturing: FDA should fully assess its efforts to encourage innovation : report to congressional committees

Publication:

Washington, DC : United States Government Accountability Office, March 2023

Subject(s):

Civil Defense -- legislation & jurisprudence
Drug Industry -- legislation & jurisprudence
Government Regulation
Legislation, Medical
Pharmaceutical Preparations -- supply & distribution
Public Health -- legislation & jurisprudence
United States
United States. Food and Drug Administration

6. Drug safety: preliminary findings indicate persistent challenges with FDA foreign inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Publication:

Washington, DC : United States Government Accountability Office, December 10, 2019

Subject(s):

Drug Industry -- legislation & jurisprudence
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

7. 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

8. Investigating out-of specification (OOS) test results for pharmaceutical production

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2022

Subject(s):

Drug Industry -- legislation & jurisprudence
Pharmaceutical Solutions
Technology, Pharmaceutical
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Opioid crisis

Author(s):

Berry, Melissa D., author

Publication:

[Toronto, Ontario] : Thomson Reuters, 20-December-2021

Subject(s):

Mental Health Services
Opioid Epidemic -- prevention & control
COVID-19
Drug Industry -- legislation & jurisprudence
Federal Government
Narcotic Antagonists
Opiate Overdose
State Government
United States

10. Some manufacturers reported inaccurate drug product data to CMS

Publication:

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

Subject(s):

Data Accuracy
Drug Industry -- legislation & jurisprudence
Government Regulation
Medicare Part B -- economics
Pharmaceutical Preparations -- economics
United States
United States. Department of Health and Human Services