Accelerated Approval Withdrawal Offers Hints On New FDA Approach

Inside Health Policy, March 4, 2024: NCHR was interviewed regarding the FDA rescinding accelerated approval for Pepaxto for multiple myeloma. We explain that the FDA’s new “’streamlined’ path to reverse approval decisions still takes years even after there is proof that patients taking the drug are more likely to die.

Read More »

FDA’s Janet Woodcock to retire early next year

STAT News, November 16, 2023: Principal Deputy FDA Commissioner Janet Woodcock will retire from the FDA in early 2024 after almost 40 years at the agency, many as a powerful and controversial leader. We explain how her legacy has tarnished the FDA’s reputation.

Read More »