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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
The FDA has released its long-awaited Quality Management System Regulation (QMSR) final rule, including a change that requires medical device manufacturers to be compliant within two years instead of the originally proposed one year. Read More
Biogen is officially pulling the plug on Aduhelm, the controversial antiamyloid antibody that dragged the company through a Congressional investigation, spurred the resignation of a top FDA official, and crashed in ignominy. Read More
AdvaMed has urged Congress to pass the Tax Relief for American Families and Workers Act of 2024 (H.R.7024) that contains a tax change that would allow businesses to deduct their research and development expenses in one year instead of over five years. 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 CDRH Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office, effective immediately, a designation that the FDA says will allow OST to adapt to and address future public health needs and challenges. 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
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More