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PharmExec23m

Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

FDA names former pharmaceutical company executive to oversee US drug program

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
BioSpace1d

From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...
BioSpace2d

FDA Opens Pilot Run of Commissioner Voucher Program

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
Modern Retina3d

Ocugen announces new SAB members and leadership changes

Modern Retina provides ophthalmology professionals with the latest advancements, research, and expert insights in retinal ...
RealClearMarkets6hOpinion

U.S. Biotech Leadership Is Being Eroded By a Skeptical FDA

Since Dr. Vinay Prasad’s appointment as a key political voice within FDA, the tone of U.S. biotech policy has shifted from ...

The FDA must be modernized for the era of personalized medicine

We need a dedicated framework that clarifies the rules, requirements and incentives for those building personalized ...