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181. Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration

182. E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Arrhythmias, Cardiac
Clinical Trials as Topic
Electrocardiography
Government Regulation
United States

183. Radioactive fallout and shelter

Publication:: [Atlanta, GA] : Public Health Service, Audiovisual Facility, 1965
Subject(s):: Radioactive Fallout
Emergency Shelter
Civil Defense
Radiation Protection
Radiation Exposure -- adverse effects
Radiation Injuries -- prevention & control

184. Special rules for the management of infants during the hot season: recommended by the Obstetrical Society of Philadelphia to the thoughtful attention of the mothers in Philadelphia : approved and published for distribution by the Board of Health

Author(s):: Obstetrical Society of Philadelphia.
Publication:: Philadelphia : E.C. Markley & Son, printers, 1875
Subject(s):: Infant Care
Diet
Hot Temperature
Philadelphia

185. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States

186. 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

187. 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

188. S12 nonclinical biodistribution considerations for gene therapy products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Genetic Therapy
Government Regulation
Research Design
United States

189. Peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, April 14, 2023
Subject(s):: Angioplasty, Balloon, Coronary
Cardiac Catheters
Device Approval
Government Regulation
United States

190. A risk-based approach to monitoring of clinical investigations questions and answers: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2023
Subject(s):: Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
Government Regulation
Research Design
Research Personnel
United States

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