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96471. Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Blood Banking -- standards
Blood Donation -- standards
Blood Donors
Donor Selection -- standards
Government Regulation
Guideline Adherence
Plasma
United States

96472. 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

96473. 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

96474. 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

96475. 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

96476. 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

96477. Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Subject(s):: Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States

96478. Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
Subject(s):: Compassionate Use Trials
Device Approval
Government Regulation
Guideline Adherence
United States

96479. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Correspondence as Topic
Device Approval
Government Regulation
Manufacturing Industry
United States
United States.

96480. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Computer Simulation
Device Approval
Government Regulation
United States