Medmarc Blog (blog.medmarc.com)
H.R. 1 Restores Deductibility of Research and Development Expenses
Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...
FDA Unveils Voucher Program for High Priority Therapeutic Products
The FDA has established a new priority review program for premarket applications for pharmaceuticals that reflects the agency’s health priorities. Under this program, the premarket review process...
AdvaMed Supportive of Three Bills for the MedTech Industry
Three bills have been introduced to Congress that may improve the prospects for manufacturers of medical devices, two of which would improve the outlook for the entire industry. The Advanced Medical...
AdvaMed Presses Senate on Urgency of Tariff Relief for Medical Devices
Tariffs placed on medical devices could impede patient access to these lifesaving products, an argument made by Scott Whitaker, President and CEO of the Advanced Medical Technology Association...
AdvaMed AI Roadmap Prods Washington to Keep Pace
The Advanced Medical Technology Association (AdvaMed) has published a policy roadmap for artificial intelligence (AI), identifying the tremendous benefits AI has to offer patients. However, AdvaMed...
Senate Confirms Marty Makary as FDA Commissioner
The U.S. Senate has confirmed surgeon Marty Makary as the commissioner of the FDA in a March 25 vote of 56-44, installing the oncological surgeon as the agency’s 27th commissioner. The Senate also...
Tariffs Again in Play as Trade Tensions Mount
The global trade picture for medical devices has become more complicated in the first weeks of 2025 as the U.S. has threatened to apply tariffs to a series of trading partners across the globe....
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...
FDA Continues Working to Prevent Device Shortages
The FDA’s Center for Devices and Radiological Health (CDRH) has limited authority to require that device makers provide notice of current and impending device shortages. Nonetheless, CDRH has...
FDA To Seek Expanded Authority for Device Shortage Reporting
The COVID-19 pandemic amplified the FDA’s focus on medical device shortages, but medical device companies are not legally required to report shortages unless the Department of Health and Human...