The FDA-regulated community witnessed many notable events during 2023 — including a federal appeals court’s upholding of the criminal convictions of two medical device company officials on charges related to alleged off-label marketing, the FDA’s issuing of a proposed rule to fully regulate laboratory developed tests (LDTs) as devices following decades of controversy about the agency’s authority over the tests, important FDA guidance dealing with device cybersecurity, new final FDA guidance on informed consent in clinical trials, and a long-awaited final rule on the use of the major statement in direct-to-consumer (DTC) TV and radio advertisements.

 

Developments during 2023 related to FDA and Drug Enforcement Administration (DEA) regulatory and enforcement activities will continue to reverberate throughout 2024 and beyond. Download this white paper to view our list of the 10 most important FDA and DEA developments of 2023 — and our view of what’s to come in the near future.