Federal Register notice: FDA submits to OMB an information collection extension Guidance for Industry: Formal Meetings between the Food and Drug Admin...
Former FDA chief counsel Rebecca Wood rejoins Sidley Austin to co-lead both the firms food, drug and medical device regulatory practice and its FDA gr...
Cook Medical gets an FDA close-out letter resolving a 2014 Warning Letter for processes related to the companys quality system at its manufacturing fa...
FDA releases its latest batch of Warning Letters that include Lernapharm (Loris), Longood Medicine and two letters to Medtronic.
FDA clears a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and neonatal patients.
Federal Register notice: FDA makes available for public comment of a revised draft document entitled Memorandum of Understanding Addressing Certain Di...
Federal Register notice: FDA announces a 11/27 public meeting entitled Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.
Trump Administration senior associate counsel to the president Stacy Cline Amin moves to FDA to serve as chief counsel.