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FDA Denies Homeopathy Petition

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FDA denies an Americans for Homeopathic Choice petition asking that some homeopathic drugs not be considered new drugs and thus no...

Significant HCT/P Deviations at Cryos International

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FDA warns Orlando, FL-based Cryos International about significant deviations from human cell, tissue, and cellular and tissue-base...

Homeopathic Drug Products Enforcement Guide

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FDA also says it expects that many homeopathic drug products will fall outside the categories of drug products that FDA intends to...

FDA Denies Petition on Scrubs as Medical Devices

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FDA denies a petition filed by attorney James Czaban involving the regulation as medical devices of surgical scrubs for daily wear...

PhRMA Issues with FDA Medical Queries

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PhRMA urges FDA to work internationally to harmonize any change in the approach to premarket safety analytics.

Device Shortages Need More Transparency: FDA

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CDRH researchers analyze the causes of medical device shortages before and during the pandemic and call for more information from ...

Coalition for Health AI Meeting Summary

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The Coalition for Health AI releases a summary of stakeholder discussions on issues that could lead to guidance to enable trustwor...

FDA Defends Training/Support of Team Biologics

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FDA defends criticism from three former FDA Team Biologics inspectors who left the agency over working conditions and complaints o...

Priority Voucher Used on Imjudo Approval

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Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was ap...

Population PK Modeling for Dosing Alternatives Guide

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Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing ...