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ICH Guide Aims to Reduce Rat Carcinogenic Studies: FDA

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FDA releases a guidance, S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals; International Council for Harmoni...

FDA Revises EUAs for Covid Serial Testing

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FDA revises the authorized uses and is requiring updates to product labeling regarding repeat (serial) testing for all currently a...

Comments on FDA Medical Queries

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Two stakeholders comment on an FDA workshop on advancing premarket safety analytics.

BMS Reblozyl Meets Endpoint in Anemia Patients

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Bristol Myers Squibb reports that its COMMANDS Phase 3 study evaluating Reblozyl (luspatercept-aamt) met its primary endpoint in f...

FDA Helping Philips to Resolve MRI-related Shortages

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FDA recommends that health care providers discuss alternative magnetic resonance imaging-guided breast biopsy options with patient...

FDA Alert on Tracheostomy Tube Shortages

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FDA alerts patients and health care providers about a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufact...

Special Protocol Assessment Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.

Info Collection on BLA Procedures

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Federal Register notice: FDA seeks comments on an information collection extension entitled Biologics License Applications Procedu...

Measuring Growth and Evaluating Pubertal Development Guide

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FDA posts a draft guidance on recommendations for measuring and recording growth, and evaluating pubertal development for evaluati...

Special Protocol Assessment Information Collection

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Federal Register notice: FDA seeks comments on an information collection extension entitled Special Protocol Assessment.