Medmarc Blog (blog.medmarc.com)
Draft Guidance
Next-generation Sequencing (NGS) the Focus of FDA Gene Therapy Guidance
The FDA has released a draft guidance on the safety assessment of gene editing as part of the agency’s framework for accelerating the development of therapies for ultra-rare diseases. The April...
FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...
FDA Product Centers Collaborate on AI Draft Guidance
The U.S. FDA posted a draft guidance for AI-enabled device software functions (DSFs) in January 2025, which provides much-needed clarity for a number of product types. All three of the agency’s...
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The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...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 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...
New FDA Draft Guidance Offers Clarity for 510(k) Requirements
The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When...
FDA Releases Draft Guidance for Implanted 510(k) Devices
In September 2023, the FDA published several new draft guidance documents for Class II, moderate-risk devices as part of the agency’s agenda to modernize the 510(k) program. One of these is a draft...
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...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions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 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...