Subjects: Drug Industry / Recently Added: Within 6 Months - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Industry ✖ Recently Added Within 6 Months ✖

1. CMS should bolster its oversight of manufacturer-submitted average sales price data to ensure accurate Part B drug payments

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2022
Subject(s):: Cost Control
Drug Costs
Drug Industry
Government Regulation
Medicare Part B
Prescription Fees
United States
Centers for Medicare & Medicaid Services (U.S.)

2. Manufacturers may need additional guidance to ensure consistent calculations of average sales prices

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2022
Subject(s):: Drug Costs
Drug Industry
Government Regulation
Medicaid
Medicare Part B
Prescription Fees
United States

3. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States

4. Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 2023
Subject(s):: Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States

5. DSCSA standards for the interoperable exchange of information for tracing of certain human, finished, prescription drugs: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Drug Industry
Government Regulation
Guidelines as Topic
Information Dissemination
Legislation, Drug
Prescription Drugs -- standards
United States

6. Nontuberculous mycobacterial pulmonary disease caused by mycobacterium avium complex: developing drugs for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Mycobacterium avium Complex -- pathogenicity
Mycobacterium Infections, Nontuberculous -- drug therapy
United States

7. Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
United States.

8. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

9. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.

10. Voluntary consensus standards recognition program for regenerative medicine therapies: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Drug Industry
Government Regulation
Reference Standards
Regenerative Medicine -- legislation & jurisprudence
Regenerative Medicine -- standards
Voluntary Programs
United States
Center for Biologics Evaluation and Research (U.S.)

11. Development and licensure of vaccines to prevent COVID-19: guidance for industry

Publication:: [Silver Spring, MD] : Center for Biologics Evaluation and Research, October 2023
Subject(s):: COVID-19 Vaccines -- standards
Drug Development
Drug Industry
Government Regulation
Vaccine Development
United States

12. Benefit-risk assessment for new drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States

13. Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):: 2-Propanol -- analysis
Drug Compounding -- standards
Drug Contamination -- prevention & control
Drug Industry
Ethanol -- analysis
Government Regulation
Methanol -- poisoning
United States

14. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2023
Subject(s):: Biological Products -- administration & dosage
Drug Dosage Calculations
Drug Industry
Drug Labeling
Drug Packaging
Government Regulation
Injections -- standards
Prescription Drugs -- administration & dosage
Product Labeling
Product Packaging
United States

15. Real-time oncology review (RTOR): guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Neoplasms -- drug therapy
United States

16. Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Outcome Assessment, Health Care
United States

17. Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Subject(s):: Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Neoplasms -- drug therapy
Patient Reported Outcome Measures
United States

18. Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2024
Subject(s):: Biotechnology
Cell Line
Drug Industry
Government Regulation
Safety
Virus Diseases
United States

19. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Benzene
Drug Compounding
Drug Industry
Government Regulation
Legislation, Drug
Pharmaceutical Preparations
United States

20. 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