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Fast Track for Type 1 Diabetes Drug

[ Price : $8.95]

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...

Overdose Crisis Gets Priority in CDER Report

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CDER director Patrizia Cavazzoni says the 2023 Drug Safety Priorities report focuses on the nations drug overdose crisis.

PhRMA Seeks More FDA Info on Rare Disease Steps

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Pharmaceutical Research and Manufacturers of America asks FDA to take some specific follow-up steps to its virtual meeting on adva...

FDA Outlines Biosimilar Educational Outreach

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FDA increases its educational outreach to decrease hesitancy with biosimilar usage.