#drug regulation

All articles tagged with "drug regulation"

Breaking: CDER chief Høeg, a skeptic of vaccines and antidepressants, expected to leave FDA, according to source

FDA Drug Division Leadership Faces Fresh Uncertainty as Tracy Beth Høeg Is Expected to Depart

The head of the FDA’s drug division, Tracy Beth Høeg, is expected to leave the agency following the recent exit of Commissioner Marty Makary, according to a source familiar with the matter.

Key Takeaways

The head of the FDA’s drug division is expected to leave, according to a source familiar with the matter.
The report follows the recent exit of Commissioner Marty Makary.

DT Editorial Team·May 16, 2026·via endpoints.news

Amgen Moves to Update Tavneos Label as FDA Pressure Intensifies

Amgen has filed a supplement to update the Tavneos label with additional warning information as the FDA continues pushing to withdraw the drug.

Key Takeaways

Amgen filed a supplement to add more information to Tavneos warning language.
The filing comes amid an ongoing dispute with the FDA.

DT Editorial Team·May 2, 2026·via endpoints.news

FDA Plans Outside Review of Broader Access to Certain Peptides

The FDA plans to convene outside advisers to discuss whether compounding pharmacies should be allowed broader manufacturing access for certain peptides, opening a consequential regulatory debate around supply, oversight,

Key Takeaways

The FDA plans an outside advisory discussion on broader access to certain peptides.
The question centers on whether compounding pharmacies should be allowed wider manufacturing room.

DT Editorial Team·Apr 15, 2026·via statnews.com

Vinay Prasad Departs FDA Amid Regulatory Turmoil

Vinay Prasad, a controversial figure at the FDA's biologics center and key ally of Commissioner Makary, is leaving the agency.

Key Takeaways

Vinay Prasad departing FDA's Center for Biologics Evaluation and Research
Was key ally of Commissioner Makary's regulatory reform agenda

DT Editorial Team·Mar 7, 2026·3 min read·via statnews.com

Health

The FDA unveils a new retention bonus program aimed at keeping experienced drug reviewers as the agency faces mounting workforce challenges.

DT Editorial Team·Mar 6, 2026·3 min read·via endpoints.news

#drug regulation

FDA Drug Division Leadership Faces Fresh Uncertainty as Tracy Beth Høeg Is Expected to Depart

Amgen Moves to Update Tavneos Label as FDA Pressure Intensifies

FDA Plans Outside Review of Broader Access to Certain Peptides

Vinay Prasad Departs FDA Amid Regulatory Turmoil

FDA Drug Division Leadership Faces Fresh Uncertainty as Tracy Beth Høeg Is Expected to Depart

Amgen Moves to Update Tavneos Label as FDA Pressure Intensifies

FDA Plans Outside Review of Broader Access to Certain Peptides

Vinay Prasad Departs FDA Amid Regulatory Turmoil

FDA Launches Bonus Pilot to Tackle Workforce Crisis