Medical Device Legal News with Sam Bernstein: Episode 11
On 18 July 2025, the European Commission (EC) published the draft guidelines on the implementation of the Foreign Subsidies Regulation (FSR Guidelines)....more
On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products...more
Newly published draft DoD Guidance for Reviewing System Security Plans (SSP) and the “NIST SP 800-171 Security Requirements Not Yet Implemented” answer some questions but may also result in an increased protest docket due to...more