Medmarc Blog (blog.medmarc.com)
FDA (6)
FDA Guidance: Rulemaking for Patient Medication Information
The FDA has issued a final guidance for the presentation of quantitative efficacy and risk information for pharmaceutical direct-to-consumer (DTC) advertising, but this is only one of two recent...
Medicare Rule for Breakthrough Devices Returns
The Centers for Medicare and Medicaid Services has resubmitted the rule for Medicare coverage of FDA breakthrough devices with a modified plan for the application and for the process of...
FDA Seeks Feedback on AI in Drug Development, Manufacturing
The FDA is working to adapt its regulatory regimes to the use of artificial intelligence (AI) across the agency’s product centers, a response to the frequent use of AI for a variety of regulated...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...
FDA Seeks Budget Authority Increase of 10% in Fiscal Year 2024
The Office of Management and Budget has released a budget request for fiscal year 2024 for all departments of the federal government, including a proposed budget for the FDA. This includes an...
The Modernization of Cosmetics Regulation Act of 2022
Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...
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...
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...