The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence (RWE) to support the marketing of medical devices, according to ...
Regulatory Affairs Professionals Society (RAPS) 5635 Fishers Lane, Suite 400 Rockville, Maryland 20852 Telephone: +1 301 770 2920 Fax: +1 301 841 7956 Email: raps@raps.org ...
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