Federal Register notice: FDA seeks comments on a new information collection on Certification of Identity for Freedom of Information Act (FOIA) and Pri...
The Senate Health, Education, Labor & Pensions (HELP) Committee postpones a vote until 4/27 on Scott Gottlieb to be the next FDA commissioner.
Reps. Ann Kuster (D-NH) and Mimi Walters (R-CA) introduce HR 2144 that would require FDA to implement an efficient, streamlined process for classifyin...
FDA issues a draft product-specific guidance for generic Narcan products as it accepts in part and denies in part several specific requests the NDA ho...
Federal Register notice: FDA, the National Science Foundation and Department of Homeland Security, Science and Technology announce a public workshop e...
FDA clears a Bausch + Lomb 510(k) for Vitesse, a hypersonic device for vitreous removal.
A Matrix Global Advisors white paper outlines five ways in which FDA can promote drug competition that should lead to lower drug prices.
FDA clears a Samsung 510(k) for the GC70 Digital Radiography (DR) system.