Medmarc Blog (blog.medmarc.com)
FDA Proposes New Formats for Informed Consent
The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...
FDA’s Quality System Final Rule a Significant Revision
The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the...
FDA Provides Greater Possibilities for Real-World Evidence
In 2023, the FDA prioritized the use of real-world evidence (RWE) for regulatory decision making for medical products, leading to the development of two guidance’s. In both cases, the FDA was...
Regulatory Partners Release guidelines for PCCPs
The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...
AdvaMed’s Innovation Agenda Highlights Patient Access, FDA Regulation
The Advanced Medical Technology Association (AdvaMed) has developed an innovation agenda for the 118th Congress, which emphasizes nine top priorities, such as the reinstatement of expensing for...
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...