Medmarc Blog (blog.medmarc.com)
Life Sciences Industry (2)
FDA Unveils Upgrades for the Agency’s Elsa AI Agent
The FDA has upgraded its Elsa artificial intelligence (AI) agent, which is now on its fourth iteration in less than a year. The upgrade comes with the integration of a data platform that will...
CMS, FDA Propose New Path for Breakthrough Devices
The Centers for Medicare & Medicaid Services and the FDA recently announced a new program that will create a more predictable route for adoption of innovative medical devices. The Regulatory...
SBIR/STTR Reauthorization Strengthens Early Stage Medtech Innovation
After a six-month hiatus, the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs are in effect thanks to passage of a bill that was signed into law...
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FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...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The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...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...