Page 13 - Docket Number News Today

Clinical / Medical

Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements

The U. S. House Committee on Natural Resources hearing held on Thursday, June 15, 2023, was singularly focused on H.R. 3397, sponsored by Rep. John R. Curtis (R-UT-3), which requires...

This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.

This document describes how CVM intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from water soluble APIs.

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).

Guidance for Industry

Clinical Pharmacology

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.

Generics