Medmarc Blog (blog.medmarc.com)
Regulatory and Compliance
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...
Mammography False Positives Endanger Screening Compliance
A new study published recently in the Annals of Internal Medicine disclosed an association between false positive results on mammography screening exams and a reluctance to return for screening....
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...
WHO Urges Nations to Adopt National Strategies for Diagnostics
In the wake of the COVID-19 pandemic, the World Health Organization has adopted a resolution that has received the backing of MedTech Europe and the Advanced Medical Technology Association...
New Extension Proposed for European Union’s Medical Device Regulation
Timelines for compliance with the European Union’s Medical Device Regulation (MDR) may be extended again via a legislative proposal recently released by the European Commission (EC), which would...
FDA Reissues CRL Guidance for Generic Drugs After Five Months
The FDA has reissued a July 2022 guidance for complete response letters (CRLs) for generic drug applications after only five months, although the December 2022 version was made necessary by the...
Congress Passes Budget Omnibus without VALID Act
The U.S. Senate and House of Representatives have concluded their work on the budget for fiscal year 2023, sending the Consolidated Appropriations Act (CAA) to the White House for President...