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Gilead Sciences Pauses Magrolimab Studies

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Gilead Sciences pauses enrollment globally in its magrolimab solid tumor studies and FDA subsequently requests (XXX TENSE XXX) a p...

CDRH Product Evaluation Head Maisel Retiring

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CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel announces he will retire this spring.

ANDA Product-Specific Guidances Added

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Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances on the design of bi...

Fast Track for Type 1 Diabetes Drug

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FDA grants Diamyd Medical a fast-track designation for Diamyd (rhGAD65/alum) and its use in improving glycemic control in some dia...

Merit Medicals SCOUT Surgical Guide Cleared

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FDA clears a Merit Medical Systems 510(k) for the SCOUT MD Surgical Guidance System for use in implanting surgical reflectors in a...

Charging for Drugs Under an IND Guidance

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FDA makes available a final guidance entitled Charging for Investigational Drugs Under an IND: Questions and Answers.

FDA Digital Transformation Office Reorganization

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Federal Register notice: FDA announces that its Office of Digital Transformation has modified its organizational structure.

62 New or Revised Product-Specific Guidances Out

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FDA publishes for public comment 29 new and 33 revised product-specific guidances.

Califf to News Media: Benefit the Public Health

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FDA commissioner Robert Califf says the recent worldwide reporting of a call to end Covid vaccines by the Florida surgeon general ...

Update FDA Social Media Enforcement: Durbin, Braun

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Sens. Durbin and Braun call on FDA to update its prescription ad guidance to reflect the explosion in social media and to prioriti...