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Medmarc Blog (blog.medmarc.com)

FDA Provides Greater Possibilities for Real-World Evidence

January 30, 2024

In 2023, the FDA prioritized the use of real-world evidence (RWE) for regulatory decision making for medical products, leading to the development of two guidance’s. In both cases, the FDA was...

Regulatory Partners Release guidelines for PCCPs

January 29, 2024

The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...

White House Announces Women’s Health Research Program

December 27, 2023

The White House has announced a program titled the Initiative on Women’s Health Research, which among other things will amplify ongoing programs at the FDA designed to improve health outcomes for...

FDA Guidance Promises Closer Scrutiny of Medical Device Cybersecurity

November 29, 2023

The FDA’s most recent final guidance for medical device cybersecurity represents a significant shift in the agency’s perspectives regarding cybersecurity, which is part of a broader emphasis on...

FTC Seeks to Remove Medical Patents from FDA’s Orange Book

November 21, 2023

The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...

FDA Releases New Draft Guidance for Unapproved Uses

November 03, 2023

The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a...

A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability

October 11, 2023

The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...

FDA Proposes End to Enforcement Discretion for Lab-Developed Tests

October 09, 2023

The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...

New FDA Draft Guidance Offers Clarity for 510(k) Requirements

October 02, 2023

The FDA has released a new draft guidance which explains when clinical data may be needed for 510(k) submissions, an essential explanation of the agency’s policy for the 510(k) program. When...

AdvaMed and CapView Propose Plan for Medicare Coverage of AI

September 25, 2023

The Advanced Medical Technology Association (AdvaMed) and CapView Strategies have collaborated to produce a series of recommendations for improving Medicare coverage of artificial intelligence (AI),...