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Implementation of Acceptable Full-Length and Abbreviated Donor History

Published: June 14, 2023

This guidance recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 2.1 dated May 2020, prepared by the Plasma Protein Therapeutics Association (PPTA).

Source: fda.gov

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Assessing User Fees Under the Generic Drug User Fee Amendments of 2022

Published: June 8, 2023

Guidance for Industry

Source: fda.gov

Related Topics:

Guidance Issuing Office Drug Administration Docket Number Drug Evaluation Generic Drug User Fee Amendments Fee Reauthorization Act Prescription Drug User Fee Act Biosimilar User Fee Act Federal Food Cosmetic Act

Clinical Drug Interaction Studies With Combined Oral Contraceptives

Published: June 8, 2023

Clinical Pharmacology

Source: fda.gov

Related Topics:

Drug Administration Guidance Issuing Office Docket Number Drug Evaluation

CFPB Issue Spotlight Analyzes How Financial Institutions Use Chatbots

Published: June 7, 2023

The bureau warns of risks with noncompliance of federal consumer financial protection laws and provides guidance on how to best use chatbots when communicating with consumers.

Source: acainternational.org