Regulatory Affairs Professionals Society

MDCG updates guidance on device classification, EMDN, and supply disruptions

The European Commission’s Medical Device Coordinating Group (MDCG) has revised several documents addressing the ...
Forbes

Rethinking Higher Education Classifications For Today’s Institutions

My 16-year-old son has a piece of paper, thumbtacked to his bedroom wall: a list of about 30 colleges and universities, carefully ordered alongside checkmarks and crosshatches. Upon first glance, the ...
JD Supra

FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification Categories for Certain Supplements under BsUFA III

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants ...
Flightglobal

US FAA studies three-category UAV classification and certification system for integration into civil airspace

The US Federal Aviation Administration is exploring potential establishment of a three-category classification and certification system for unmanned air vehicles as part of a roadmap for UAV ...