White House backs FDA head after ouster of top regulator

The administration, as well as HHS, publicly praised Marty Makary’s leadership despite persistent upheaval at the agency.
BioWorld

FDA’s CDER helmless again, amid bribery, defamation claims

The U.S. FDA once again has a leadership gap at the top of its drug center, which already has been ravaged this year by massive terminations, resignations and retirements of senior leaders. George ...

FDA’s top drug regulator sued by drug company, resigns amid conduct probe

The top drug regulator at the Food and Drug Administration (FDA) resigned Sunday, according to officials, after being accused ...
BioWorld

Three months later, FDA’s CDER helmless again

George Tidmarsh, a biopharma industry veteran who’s helmed CDER for a little more than three months, resigned yesterday after being placed on administrative leave two days earlier amid a Health and ...
FiercePharma

FDA names next CDER director in biotech vet George Tidmarsh

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and Research (CDER) in veteran biotech executive George Tidmarsh, M.D., Ph.D.

FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’ about his conduct

The head of the Food and Drug Administration’s drug center abruptly resigned Sunday amid concerns about his personal conduct. A federal spokesperson said Dr.
Green Matters on MSN

FDA Recalls More Than 140,000 Bottles of Cholesterol Medications Due to High Health Risk They Pose

Massive recall of 141,984 bottles of Cholesterol medicine gets an update. In September, the Food and Drug Administration ...
FiercePharma

FDA official challenges safety, efficacy of Aurinia lupus med in now-deleted LinkedIn post targeting surrogate endpoints

A now-deleted LinkedIn post from a top FDA official has raised the hackles of Aurinia Pharmaceuticals as industry watchers puzzle over the official's decision to target the approvability of surrogate ...
FierceBiotech

UPDATE: Analyst questions impact of FDA's rare disease pathway proposal

The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...