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Federal Register

Info Collection of Device Shortages Data

Federal Register notice: FDA seeks comments on an information collection extension for Shortages Data Collections.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include CooperSurgical and Dr. Paul's Lab.

Human Drugs

GSK Wants Changes to OTC Drug Naming Guidance

GSK Healthcare asks FDA to change its approach in a draft guidance on labeling OTC drugs.

Biologics

Pacific Stem Cells Selling Unapproved Products: FDA

FDA says Pacific Stem Cells is marketing unapproved stem cell products to treat several diseases and conditions.

Biologics

Study Finds Lack of Minority Groups in Vaccine Trials

A new study finds that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials.

Federal Register

Info Collection on GMPs for Blood and Components

Federal Register notice: FDA seeks comments on an information collection extension entitled Current Good Manufacturing Practices and Related Regulatio...

Federal Register

Info Collection on Blood Cell Separator Guidance

Federal Register notice: FDA seeks public comments on an information collection extension associated with its Guidance for Industry and FDA Staff Cla...

Federal Register

Info Collection Extension for CVM Dispute Resolution

Federal Register notice: FDA sends to OMB an information collection extension entitled Dispute Resolution Procedures for Science-Based Decisions on Pr...

Human Drugs

AstraZenenca Withdraws Imfinzi Bladder Cancer Use

AstraZeneca withdraws an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or metastatic bladder cance...

Human Drugs

2 Guides Address Product Development and Covid Variants

FDA issues a new guidance and revises another to assist vaccine, diagnostic and therapeutic product developers to address the emergence and potential ...