Company sought court order to vacate agency’s approval of the fibrinogen products of three blood centers, saying they were wrongly exempt from clinical trials required for Octapharma’s Fibryga.
Seventeen months after Octapharma USA Inc sued the US Food and Drug Administration to compel the agency to rescind approval of plasma-derived fibrinogen products sponsored by three blood centers, the parties agreed to dismissal of the complaint.
Before the suit was dropped, Octapharma and the agency noted in joint status reports to the court that they were...
The appointment of longtime FDA oncology leader Richard Pazdur to lead FDA's Center for Drug Evaluation and Research is being well received.
The requested changes to the class-wide warnings for hormone replacement therapies mark the first time one of Makary’s expert panels sparked regulatory action and could lead to broader scrutiny of their use.
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.
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.
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.
Employees subject to the April 1 reduction-in-force began noticing severance payments had been stopped the week of Nov. 3, before the FDA Office of Human Capital Management announced the suspension of all payments to former staffers due to the lapse in appropriations.
