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FDA Pledges Prompt CRL Release

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FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transm...

Medtronic Recalls DLP Left Heart Vent Catheters

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Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the ...

FDA Posts Alopecia Complex Case Study

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FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participant...

Prasad Has Covid YouTube Videos Pulled

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The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube ch...

Boehringer Gets Breakthrough Status for Hernexeos

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FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatmen...

FDA Rare Disease Evidence Principles

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CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review...

CBER Raising Bar on Future Covid Vaccines

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Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination...

FDA Accepts NDA for Smoking Cessation Drug

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FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to q...

AI Can Cut Drug Development Costs, Time: Experts

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Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in ...

CGMP Violations at Amneal Gujarat, India

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FDA warns Amneal Pharmaceuticals about CGMP violations in its Gujarat, India, drug manufacturing facility.