Article Summary:
This week, the FDA has made several updates and announced upcoming events related to digital health, drug regulation, and medical device oversight. The agency has updated two guidances to ease its oversight of general wellness devices and clinical decision support software, aiming to bolster the adoption of AI-enabled digital health products.
The FDA has scheduled public meetings on generic drug development, challenges in designing Phase 3 trials for rare diseases, and the implementation of its Quality Management System Regulation. The Centers for Disease Control and Prevention has also updated its childhood vaccination recommendations, reducing the number of vaccines broadly recommended.
In the drugs and biologics domain, the FDA has updated its policies on posting new safety information, published meeting minutes from user fee negotiations with the drug industry, and approved several new treatments, including Aqvesme for thalassemia, Yartemlea for stem cell transplant-associated thrombotic microangiopathy, and Myqorzo for obstructive hypertrophic cardiomyopathy.
For medical devices, the FDA has proposed launching a new iteration of its Total Product Lifecycle Advisory Program and developing additional IT tools to facilitate interactions with manufacturers. The agency has also emphasized international harmonization in its device user fee negotiations, focusing on areas like harmonized pre-market reviews and increasing the frequency of meetings with global regulatory authorities.
Overall, the FDA is working to streamline its oversight, support the development of innovative digital health and medical products, and enhance its collaboration with industry and international partners.