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1. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, December 2017
Subject(s):: Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.

2. Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Cannabis
Drug Development
Government Regulation
Medical Marijuana
United States
United States. Food and Drug Administration

3. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

4. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

5. Pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2020
Subject(s):: Clinical Studies as Topic
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Patient-focused drug development: collecting comprehensive and representative input : guidance for industry, Food and Drug Administration staff, and other stakeholders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Development
Feedback
Sampling Studies
Patient Reported Outcome Measures
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Community-acquired bacterial pneumonia: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Community-Acquired Infections
Drug Development
Pneumonia, Bacterial -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2020
Subject(s):: Drug Development
Healthcare-Associated Pneumonia -- drug therapy
Pneumonia, Bacterial -- drug therapy
Pneumonia, Ventilator-Associated -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. Eosinophilic esophagitis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Development
Eosinophilic Esophagitis -- drug therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

11. Controlled correspondence related to generic drug development

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. Science and tech spotlight: COVID-19 vaccine development

Publication:: [Washington, DC] : United States Government Accountability Office, May 2020
Subject(s):: COVID-19 Vaccines -- therapeutic use
Drug Development
United States

13. COVID-19: federal efforts accelerate vaccine and therapeutic development, but more transparency needed on emergency use authorizations : report to Congressional addressees

Publication:: Washington, DC : United States Government Accountability Office, November 2020
Subject(s):: COVID-19 Vaccines
Drug Approval
Drug Development
Disclosure
United States
United States. Department of Defense
United States. Department of Health and Human Services

14. Premenopausal women with breast cancer: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Breast Neoplasms -- drug therapy
Drug Development
Premenopause
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

15. Bispecific antibody development programs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Antibodies, Bispecific
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. Development of anti-infective drug products for the pediatric population

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):: Anti-Infective Agents
Drug Development
Pediatrics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

17. Questions and answers on biosimilar development and the BPCI Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
Subject(s):: Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

18. Providing regulatory submissions in alternate electronic format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
Subject(s):: Biological Products
Drug Approval
Drug Development
Electronic Mail
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

19. Human gene therapy for rare diseases

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):: Drug Development
Genetic Therapy
Rare Diseases -- therapy
Clinical Trials as Topic
Drug Evaluation, Preclinical
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Population pharmacokinetics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Subject(s):: Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Pharmacokinetics
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

21. Pre-Launch Activities Importation Requests (PLAIR)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Dosage Forms -- standards
Drug Approval
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

22. Drug products, including biological products, that contain nanomaterials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Products -- standards
Drug Approval
Drug Development
Nanostructures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

23. Chronic hepatitis B virus infection: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Drug Approval
Drug Development
Hepatitis B -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

24. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):: Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

25. Opioid use disorder: developing depot buprenorphine products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2019
Subject(s):: Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

26. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):: Drug Development
HIV Infections -- prevention & control
Pre-Exposure Prophylaxis
Adolescent
Child
Clinical Trials as Topic
HIV Infections -- drug therapy
HIV-1
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

28. Uncomplicated urinary tract infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Clinical Trials as Topic
Drug Development
Urinary Tract Infections -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

29. Bacterial vaginosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

30. Vulvovaginal candidiasis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Candidiasis, Vulvovaginal -- drug therapy
Clinical Trials as Topic -- standards
Drug Development
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

31. Q9(R1): : quality risk management : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Risk Management
United States

32. Smoking cessation and related indications: developing nicotine replacement therapy drug products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Development
Government Regulation
Nicotine Chewing Gum
Smoking Cessation
Smoking Cessation Agents
Tobacco Use Cessation Devices
United States

33. Q13 continuous manufacturing of drug substances and drug products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Biological Products
Drug Compounding
Drug Development
Drug Industry
Government Regulation
United States

34. Chronic rhinosinusitis with nasal polyps: developing drugs for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Nasal Polyps -- drug therapy
Sinusitis -- drug therapy
United States

35. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):: Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration

36. 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

37. 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

38. 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

39. 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

40. 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

41. Rare diseases: considerations for the development of drugs and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Drug Development
Drug Industry
Government Regulation
Rare Diseases -- drug therapy
United States