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6. Getting to the root of high prescription drug prices: drivers and potential solutions

Author(s):
Waxman, Henry, author
Corr, Bill, author
Martin, Kristi, author
Duong, Sophia, author
Publication:
[New York, N.Y.] : Commonwealth Fund, July 2017
Subject(s):
Cost Control
Drug Costs
Health Policy
Prescription Drugs -- economics
Drug Industry -- economics
Drugs, Generic -- economics
Economic Competition
Legislation, Drug
Orphan Drug Production -- economics
Humans
United States

8. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

11. National Institutes of Health: Better data will improve understanding of federal contributions to drug development : report to congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, April 2023
Subject(s):
Biomedical Research -- economics
Drug Development -- economics
Financing, Government -- organization & administration
Government Regulation
Health Occupations -- education
Legislation, Drug
United States
National Institutes of Health (U.S.)

13. Exemption and exclusion from certain requirements of the Drug Supply Chain Security Act for the distribution of FDA-approved naloxone products during the opioid public health emergency: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):
Government Regulation
Legislation, Drug
Naloxone -- supply & distribution
Opioid Epidemic -- prevention & control
United States
United States. Food and Drug Administration

15. A sense of déjà vu: the debate surrounding state biosimilar substitution laws

Author(s):
Purvis, Leigh, author
Publication:
Washington, D.C. : AARP Public Policy Institute, September 2014
Subject(s):
Biological Products -- economics
Biological Products -- therapeutic use
Biosimilar Pharmaceuticals -- economics
Biosimilar Pharmaceuticals -- therapeutic use
Drug Costs
Drug Substitution
Legislation, Drug
Drugs, Generic -- economics
Federal Government
State Government
Humans
United States
United States. Food and Drug Administration.
United States.

16. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

18. Providing regulatory submissions for medical devices in electronic format: submissions under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, July 15, 2020
Subject(s):
Electronic Data Processing -- legislation & jurisprudence
Legislation, Drug
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Drug safety: COVID-19 complicates already challenged FDA foreign inspection program : testimony before the Committee on Finance, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, June 2, 2020
Subject(s):
Pharmaceutical Preparations -- supply & distribution
Drug Contamination -- legislation & jurisprudence
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration

27. Cost savings

Author(s):
Steiner, David J., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Cost Control -- legislation & jurisprudence
Cost Savings
Drug Costs -- legislation & jurisprudence
Economics, Pharmaceutical
Legislation, Drug
Access to Information
Biosimilar Pharmaceuticals
Commerce
Conflict of Interest
Drug Industry
Insurance, Pharmaceutical Services
Managed Care Programs
Medicaid -- economics
Medicare Part D -- economics
Patents as Topic
State Government
Humans
United States

28. Medicare Part D

Author(s):
Steiner, David J., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Drug Costs
Medicare Part D -- economics
Medicare Part D -- legislation & jurisprudence
Biosimilar Pharmaceuticals -- economics
Cost Control -- legislation & jurisprudence
Drugs, Generic -- economics
Economics, Pharmaceutical
Financing, Personal
Fraud
Legislation, Drug
Medicare Part C
Opioid-Related Disorders
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

29. 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
Analgesics, Opioid
Crime
Equipment Failure
Equipment Safety
Federal Government
Fraud
Medical Device Recalls
Opioid-Related Disorders -- epidemiology
Patents as Topic
Prescription Drug Diversion
Humans
United States

30. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

31. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):
Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

33. Compounding certain ibuprofen oral suspension products under section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):
Administration, Oral
Drug Compounding -- methods
Drug Compounding -- standards
Drug Industry
Government Regulation
Ibuprofen
Legislation, Drug
Suspensions
United States
United States. Food and Drug Administration
United States.

38. Direct-to-consumer prescription drug advertisements: presentation of the major statement in a clear, conspicuous, and neutral manner in advertisements in television and radio format final rule : questions and answers : guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):
Direct-to-Consumer Advertising -- legislation & jurisprudence
Drug Industry
Government Regulation
Legislation, Drug
Prescription Drugs
United States

43. The traffic in habit-forming narcotic drugs: hearings before the Committee on Foreign Affairs, House of Representatives, Sixty-eighth Congress, first session on H. J. Res. 195 authorizing an appropriation for the participation of the United States in the two international conferences for the control of the traffic in habit-forming narcotic drugs : February 21, 1924 : Statement of the attitude of the government of the United States with documents relating thereto = Le trafic des drogues narcotiques : séances du Comité des Affaires etrangères, Chambre des Représentants, soixante huitiéme congrès, première session, resolution de la Chambre no. 195 accordant un crédit pour la participation des Etats-Unis aux deux conférences internationales du contrôle de l'opium : 21 février 1924 : Déclaration sur l'attitude du Gouvernment des Etats-Unis augmentée des documents s'y référant

Author(s):
Erk, Edmund Frederick, 1872-1953 compiler
Publication:
Washington : Government Printing Office, 1924
Subject(s):
Budgets -- legislation & jurisprudence
Drug and Narcotic Control
Legislation, Drug
Opium
Substance-Related Disorders
United States