Commissioner Kyle Diamantas touted the agency’s new rare disease framework as the best mechanism for modernizing rare disease ...
Australia's Therapeutic Goods Administration (TGA) is holding a consultation into a planned temporary increase to medical device annual charges.
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 ...
Left to right: Donielle Johnson, Simon Mason, Daniel Caños, Juan Espinoza, and Heather Colvin spoke at the 2026 Medtech Conference. (credit: Ferdous Al-Faruque) BOSTON – There needs to be a cultural ...
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 US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
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 ...
Regulatory and quality professionals work in an environment that requires constant learning and connection. To keep up with changes in healthcare and healthcare regulation, across medical devices, ...
Major pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drugs ...
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