On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to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
4/26/2019
/ Biotechnology ,
Draft Guidance ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Medical Devices ,
Pharmaceutical Industry ,
Product Recalls ,
Regulatory Oversight ,
Strategic Planning
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more
8/4/2017
/ Compliance ,
Enforcement ,
Food and Drug Administration (FDA) ,
Foreign Manufacturers ,
Imports ,
Inspections ,
Medical Devices ,
Product Recalls ,
Risk-Based Approaches ,
Safety Inspections ,
Trump Administration