Negotiations between the U.S. FDA and industry over device user fees were a protracted struggle, but the agency was demonstrably loathe to post the minutes from meetings between the agency and industry representatives. Jeff Shuren, director of the FDA’s device center, said in a congressional hearing that those minutes were not posted because of a need to wrap up the negotiations rather than allow outsiders – including members of Congress – to see how difficult the negotiations had become.
The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration.
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
The FDA cleared a peripheral vascular occlusion product developed by Artio Medical Inc. The Solus Gold embolization device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
Even though Congress isn’t likely to approve BsUFA III for several months, the FDA is getting a jump on one of the BsUFA commitments it negotiated with industry to pilot a regulatory science program to facilitate the development of biosimilars and interchangeables.
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
DUBLIN – The EMA has rejected Biogen Inc.’s application for European Union approval of Aduhelm (aducanumab), its controversial Alzheimer’s disease drug. Its human medicines committee (CHMP) issued a negative opinion on Biogen’s dossier during its December meeting this week, stating that the data from the key studies submitted in support of the application “were conflicting and did not show overall that Aduhelm was effective at treating adults with early stage Alzheimer’s disease.”
The FDA added its green light to Klox Technologies Inc.’s Lumiheal fluorescent and blue light therapy system with de novo clearance for scar management of post-surgical incisions. The system uses fluorescence biomodulation technology to activate cellular processes and treat skin and soft tissue disorders.
Cardiologist Robert Califf has been nominated a second time to lead the FDA, and drug pricing was again high on the agenda at the Dec. 14 Senate hearing for his nomination.
