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FTC Broadens Reach of Health Products Compliance Guidance

March 6, 2023

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 cover...

Ethylene Oxide Issues Resurfacing after EPA Announcement

February 7, 2023

The Environmental Protection Agency has restarted the process of evaluating emissions standards for ethylene oxide (EtO), the sterilant responsible for sterilization of billions of medical products in...

New Extension Proposed for European Union’s Medical Device Regulation

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...

FDA Reissues CRL Guidance for Generic Drugs After Five Months

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...

Congress Passes Budget Omnibus without VALID Act

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...

FDA Enables Safeguarding Therapeutics Act in Guidance

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...

FDA Releases Cybersecurity Modernization Plan

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...

FDA Issues Cybersecurity Action Plan for Agency IT Systems

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...

FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule

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...

FDA Revisits Validation for Production Computer Systems

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...

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