Medmarc Blog (blog.medmarc.com)
Clinical Trials
Effective Supplier Oversight in Medical Device Manufacturing
Medical device manufacturers rarely operate in isolation. Today’s products are often developed through a complex network of contract manufacturers, sterilization providers, software developers,...
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....
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FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...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The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...
Impact of Federal Funding Freeze on Clinical Trials and Patient Safety
In January 2025, the Trump administration implemented a temporary freeze on federal financial assistance programs, including grants and loans, to review their alignment with the administration’s...
GAO Report Highlights FDA Staff Shortages for BiMo Inspections
The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such...
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The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...