Promo materials should also refrain from positioning one approved biosimilar as better than another for the same reference product, per the document, and they shouldn’t suggest that a biosimilar is ...
Forbes contributors publish independent expert analyses and insights. Fred L. Smith Jr. Fellow at the Competitive Enterprise Institute. The 2024 Federal Register hit 86,712 pages October 30, the third ...
FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" is probably the most used ...
The Consumer Financial Protection Bureau (CFPB), which is undergoing significant changes under the Trump administration, has rescinded 67 guidance documents issued since 2011, including several that ...