Under a federal judge’s order, FDA must reverse its denial of the Center for Reproductive Rights’ 12-year-old citizen petition and allow universal OTC access to Plan B One-Step and equivalent levonorgestrel-based emergency contraceptives within 30 days.
Plan B One-Step and equivalent emergency contraception products must be approved for universal OTC access by May 4, under a federal judge’s ruling against FDA and the Department of Health and Human Services.
Twelve years after being filed and more than a year after being denied, the Center for Reproductive Rights’ citizen petition...
The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.
The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.
A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
