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Start Over Subjects Government Regulation ✖Remove constraint Subjects: Government Regulation Recently Added Within 6 Months ✖Remove constraint Recently Added: Within 6 Months Publication Year 2023 ✖Remove constraint Publication Year: <span class="single" data-blrl-single="2023">2023</span>

32. 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.

33. 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.

34. 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.)

38. 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

40. 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