Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
FDA Plans to Restart On-Site Inspections the Week of July 20 -Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to...more
On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more
Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more
In the flurry of legislation passed by the 111th Congress in its final days, the Food Safety and Modernization Act (FSMA) cleared the Senate by unanimous voice vote on December 20, passed the House 215-144 the following day,...more