Case studies demonstrating what kinds of drugs do and don’t qualify for the expedited pathway designation will be presented at an April workshop co-sponsored by the Brookings Institution.
FDA is hoping that greater transparency around the “breakthrough therapy” designation process will reduce the number of time-consuming, frivolous requests it receives for the coveted designation.
Much of the resource drain created by the breakthrough program results from having to evaluate requests for designation that are...
The next iteration of the user fee program could depart from longstanding agency commitments to issue formal guidance given the Trump Administration’s deregulatory philosophy, policy experts said.
Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.
The FDA deputy commissioner emailed staff asking anyone interested in the position to send her their curriculum vitae, an unusual method for finding candidates for a high-level position.
Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
The $245 price agreed to by both firms may be in line with the maximum fair price that Medicare negotiated for Novo Nordisk’s semaglutide products.
The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.
