Medmarc Blog (blog.medmarc.com)
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The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...
FDA’s Quality System Final Rule a Significant Revision
The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the...
FDA Provides Greater Possibilities for Real-World Evidence
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
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
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
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
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FDA Releases New Draft Guidance for Unapproved Uses
The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available.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
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
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...