FDA has hired an outside firm, Eastern Research Group, to help assess the performance of the new review “Program” for novel drugs and biologics under PDUFA V. That assessment – which will be discussed at two public meetings – will help determine the future of FDA’s new review process after 2017.
Drug sponsors meeting with the Food & Drug Administration during the review of new molecular entities or novel biologics are seeing a new face at the table: consultants from Lexington, Mass.-based Eastern Research Group.
ERG is under contract with FDA to assess the performance of the agency’s new review process under Prescription Drug User...
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.
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.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
