Regulatory Roundup: FDA, CMS, Medicaid Launch Pilot Program to Conduct Parallel Reviews of Medical Devices

FDA released this week a final guidance on anticounterfeiting excipients. The guidance recommends that any physical–chemical identifier incorporated into solid oral dosage forms of drugs be pharmacologically inactive. Quality, potency, and bioavailability are also discussed.

FDA, the Centers for Medicare (CMS), and Medicaid launched a pilot program last week to conduct parallel reviews of medical devices, which are seeking FDA approval as well as Medicare coverage. “The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies,” according to an agency press release. The two-year pilot is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination.

FDA also announced a joint study with NIH on tobacco use and risk. The large-scale, national study will monitor tobacco users to assess the behavioral and health impacts of new government tobacco regulations, namely the 2009 Family Smoking Prevention and Tobacco Control.