Medmarc Blog (blog.medmarc.com)
How Clinical Trial Vendors Can Quietly Expand a Sponsor’s Products Liability Exposure
As clinical trials become increasingly decentralized and operationally complex, sponsors are relying on a growing network of third party vendors to support execution of the clinical trial protocol....
Electronic Labeling Bill in Process in the U.S. Senate
Congress is considering several bills that may affect companies in the life sciences, particularly in connection with medical devices and in vitro diagnostics. One bill that is in play in the...
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...
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The FDA has released a draft guidance on the safety assessment of gene editing as part of the agency’s framework for accelerating the development of therapies for ultra-rare diseases.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FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...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The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials.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...