Medmarc Blog (blog.medmarc.com)
FDA (6)
FDA Informed Consent Guidance Subject to Near-Term Changes
On Aug. 15, 2023, the FDA released a guidance for informed consent which states that a medical device clinical trial may not proceed until the sponsor addresses the agency’s concerns regarding the...
FDA Encountering Strong Opposition to CDS Final Guidance
The FDA guidance for clinical decision support (CDS) programs was intended to provide clarity for this important category of device products, but the guidance has run into unexpected headwinds....
Merger Reviews in U.S. to be More Closely Scrutinized
The U.S. federal government is considering a more careful review of mergers and acquisitions per a proposal announced recently by the U.S. Department of Justice (DoJ) and the Federal Trade...
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FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions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...