Subjects: Drug Development - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Development ✖

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