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FDA announces generative AI pilot and rapid rollout plans

The FDA has completed a pilot of a new GenAI technology for speeding up drug reviews– And it wants to move from pilot to implementation in two months

News

FDA ramps up unannounced inspections of foreign facilities

Trump orders the FDA to ease the commissioning of domestic manufacturing facilities, as the regulator announces more unannounced foreign inspections.

News

Vinay Prasad will replace Marks as CBER director

COVID-19 vaccine mandate critic Vinay Prasad has been named as director of the FDA's Center for Biologics Evaluation and Research (CBER).

News

Senior FDA resignations gut drug advertising function

Two senior officials at the FDA's drug promotion office have resigned, leading to speculation that a clampdown on some advertising may be on the way.

Market Access

Working in the grey: FDA, CMS and data privacy

For companies in the biotech space, it’s never been easy to navigate the legal and business risks inherent in a highly regulated, dynamic industry – and it’s only becoming more complicated

Market Access

New FDA head says no more pharma on advisory committees

The announcement signals a new administration attempting to distance itself from industry, but the actual impact seems small.

FDA announces generative AI pilot and rapid rollout plans

FDA ramps up unannounced inspections of foreign facilities

Vinay Prasad will replace Marks as CBER director

Senior FDA resignations gut drug advertising function

Working in the grey: FDA, CMS and data privacy

New FDA head says no more pharma on advisory committees

Protego's $130m for amyloidosis drug, and other financings

How to meet your physicians where they are online

FDA

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