www.ema.europa.eu
EMA establishes regular procedure for scientific advice on certain high-risk medical devices | European Medicines Agency (EMA)
Manufacturers can request advice on their medical device clinical development programme
#MedicalDevices is an active hashtag on Bluesky. In the last 30 days, 26 people shared 55 posts with it — around 2 a day. Activity is up 8% versus the previous week, peaking on Sep 3 with 6 posts.
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www.ema.europa.eu
EMA establishes regular procedure for scientific advice on certain high-risk medical devices | European Medicines Agency (EMA)
Manufacturers can request advice on their medical device clinical development programme
healthcaretoday.com
MHRA regulatory reform amendments tabled
Introduced in the government’s Health Bill, they aim to support information sharing, regulatory reform and the future development of a medical device licensing regime.
www.ema.europa.eu
New pilot to support development of ‘breakthrough’ medical devices | European Medicines Agency (EMA)
Enhanced regulatory support and priority access to scientific advice for developers
www.axios.com
Trump to tap Heidi Overton as FDA commissioner
Overton is currently a White House aide.
www.fiercehealthcare.com
FDA advisory committee to roll up sleeves on generative AI this week
The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. | The FDA seeks advice o...
apnews.com
Trump administration cuts reach FDA employees in food safety, medical devices and tobacco products
The Trump administration’s effort to slash the size of the federal workforce reached the Food and Drug Administration this weekend.
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