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The FDA has issued a revised version of its Biosimilar User Fee Amendment (BsUFA) Research Roadmap and a list of guidances CBER plans to issue during 2024, both intended to clarify the agency’s priorities for 2024. Read More
Establishing the magnitude of the Philips Respironics recall, the FDA has announced that since April 2021, the agency has received more than 116,000 medical device reports (MDR), including 561 reports of deaths, associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the company’s ventilators, BiPAP machines, and CPAP machines. Read More
The FDA will have to exponentially ramp up its hiring to properly understand and regulate quickly developing AI and the many ways it’s poised to change development of drugs and devices, said FDA Commissioner Robert Califf. Read More
Thirty-five amicus briefs on the issue of the FDA’s approval of the abortion drug mifepristone landed in the Supreme Court of U.S. on Tuesday, all in support of the FDA’s position, from submitters ranging from single associations to groups with more than 600 members. Read More
Responding to changes required by the 21st Century Cures Act, the FDA has unveiled its principles for post market surveillance of drug safety in the final version of a 2019 draft on the subject. Read More
The FDA has until March 5 to provide an answer for Vanda Pharmaceuticals’ five-year quest to understand why the FDA denied the company’s supplemental New Drug Application (sNDA) for Hetlioz (tasimelteon) — filed in October 2018 — as a treatment for jet lag disorder, a federal judge has ruled. Read More
The FDA has expanded its use of in-person face-to-face (FTF) meetings for additional application types, and have expanded its definition of FTF meetings to include hybrid meetings which combine in-person and virtual attendance. Read More
In this edition of Quick Notes, we hop across the pond to check out the EMA’s new regulatory fees structure, its updated submissions communication portal, and the sixth update of its guideline on the clinical evaluation of anticancer medicinal products. Read More
Strong nonclinical testing should underpin development programs for both gene editing (GE) products and chimeric antigen receptor (CAR-T) cellular products, according to two new final guidances issued by the FDA. Read More