Archive for January 2024

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily