January 24, 2023
Timelines for compliance with the European Union’s Medical Device Regulation (MDR) may be extended again via a legislative proposal recently released by the European Commission (EC), which would also...
January 20, 2023
The FDA has reissued a July 2022 guidance for complete response letters (CRLs) for generic drug applications after only five months, although the December 2022 version was made necessary by the newest...
December 28, 2022
The U.S. Senate and House of Representatives have concluded their work on the budget for fiscal year 2023, sending the Consolidated Appropriations Act (CAA) to the White House for President Biden’s...
December 22, 2022
The FDA has had the authority to destroy counterfeit drugs since 2012, when Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA), but Congress did not grant the FDA the...
December 9, 2022
The FDA has released an action plan for modernizing the agency’s cybersecurity capabilities, a component of the FDA digital transformation project. This plan uses the Zero Trust paradigm for...
December 5, 2022
The FDA has released an action plan to update its approach to internal cybersecurity, the Cybersecurity Modernization Action Plan (CMAP). This plan will improve the agency’s overall standing with...
December 1, 2022
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter than Health...
November 9, 2022
The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
October 26, 2022
The new FDA final guidance for post-approval studies (PAS) accelerates some of the timelines in the previous version, and introduces some new deadlines to this policy. These changes are the same as...
October 25, 2022
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types of...
