Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
The biologics center director reportedly became personally involved after the team reviewing the rare blood disorder filing asked for an extension to the CNPV-accelerated timeline.
The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.
Companies who run their early-stage clinical development outside the U.S. would “experience higher fees” according to an FDA proposal made during the negotiation process for the eighth cycle of the user fee program.
With no evidence to support the claim that 10 children died due to COVID-19 vaccines, experts unpack the impact of CBER chief Vinay Prasad’s leaked vaccine memo.
Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
A source familiar with the matter said the White House initially requested the resignation of Sanjula Jain-Nagpal, a policy and research official at the FDA.
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