Discover how biomarkers are used across the clinical development pathway and what happens when biomarker strategy meets the European regulatory landscape. This interactive workshop combines essential ...
SGS is excited to bring to the GTA a comprehensive full-day symposium focused on the medical device industry. In partnership with the RAPS Ontario Chapter, the leading association for regulatory ...
An expert and officials from the US Food and Drug Administration (FDA) offered tips for de novo classification requests and ...
The US Food and Drug Administration (FDA) on Tuesday issued draft guidance laying out its proposed regulatory approach to ...
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. TGA has reformed medical device pathways in recent ...
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 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 ...
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 ...
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