Medmarc Blog (blog.medmarc.com)
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The FDA has released a draft guidance on the safety assessment of gene editing as part of the agency’s framework for accelerating the development of therapies for ultra-rare diseases.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 Updates Patient Preference Guidance
A The FDA has released the final guidance on the use of patient preference information (PPI), an update of an earlier guidance. The new PPI guidance is applicable across the entire product life...
Clinical Trial Agreements as a First Line of Liability Defense
Clinical trial agreements (CTAs) are often treated as administrative documents, but in reality, they are one of the earliest opportunities to shape how liability will be allocated if something goes...
FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...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’s Drug, Biologics Centers Release Primary Bayesian Guidance
The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...
FDA’s Software Assurance Guidance Emphasizes Risk Management
The FDA’s guidance for computer software assurance (CSA) is not a groundbreaking policy document, but the guidance provides insight into how much effort a manufacturing site must put into verifying...
FDA’s QMSR Final Rule Now in Effect
The FDA’s Quality Management System Regulation (QMSR) is effective as of Feb. 2, 2026, two years after publication of the QMSR final rule. This new regulatory framework requires that manufacturers...
New 2026 FDA Wellness Guidance Provides Broader Exemptions
The FDA’s Jan. 6 guidance for general wellness products does not represent a wholesale overhaul of the previous version, but developers of these products may find that more of their products will...
FDA Overhauls Guidance for Clinical Decision Support
The FDA’s Center for Devices and Radiological Health has reissued its guidance for clinical decision support (CDS) software in a rewrite that significantly relaxes the regulatory qualifications for...
FDA’s Tightens Oversight of Cybersecurity in New Guidance
Recent security breaches at healthcare institutions have amplified the U.S. government’s concerns over cybersecurity, a fact reflected in the FDA’s most recent guidance on the subject. The June 2025...