Medmarc Blog (blog.medmarc.com)
FTC Broadens Reach of Health Products Compliance Guidance
In December 2022, the Federal Trade Commission released an update to a 1998 set of guidelines for advertising and promotion of health products, but while the 1998 guidance was understood to...
New Extension Proposed for European Union’s Medical Device Regulation
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...
FDA Reissues CRL Guidance for Generic Drugs After Five Months
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...
Congress Passes Budget Omnibus without VALID Act
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...
FDA Enables Safeguarding Therapeutics Act in Guidance
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 Releases Cybersecurity Modernization Plan
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...
FDA Issues Cybersecurity Action Plan for Agency IT Systems
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...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
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...
FDA Revisits Validation for Production Computer Systems
The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
FDA Post-Approval Studies Guidance Applies Tighter Timelines
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...