Medmarc Blog (blog.medmarc.com)
Risk Management
FDA Takes Aim at Personalized Medicine in New Draft Guidance
Personalized medicine has long been the objective of the FDA and its regulated industries, and a new draft guidance from the FDA’s drug and biologics centers would seem to suggest that the era of...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The FDA’s centers for pharmaceuticals and biologics have released a draft guidance specific to Bayesian methods for support of primary inference in clinical trials. The draft guidance was posted...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...
The Modernization of Cosmetics Regulation Act of 2022
Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
Congress Passes FDA User Fee Legislation
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
FDA Electromagnetic Compatibility Guidance Covers Investigational Devices
The FDA has released a final guidance for electromagnetic compatibility (EMC) for medical devices, a policy that applies to PMA, 510(k), and de novo devices. However, the scope of the guidance also...