Examining the evolving dynamics between EU and FDA regulations for medical devices. The webinar will address the historical practice of obtaining a CE Mark in Europe first, contrasting it with the ...

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological ...

Several local independent pharmacies warn they may go out of business unless there’s more regulation on pharmacy benefit managers, or PBMs, who play a pivotal role in drug pricing. Lawmakers ...

MDIC advances regulatory science for medical devices to ensure that the best healthcare ... MDIC congratulates Dr. Michelle Tarver, Director of FDA’s CDRH, and celebrates her commitment to ...

The U.S. Food and Drug Administration has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with ...

Oct 22 (Reuters) - The U.S. Food and Drug Administration on Tuesday approved Pfizer's (PFE.N), opens new tab RSV vaccine for the prevention of lower respiratory tract disease caused by RSV in ...

Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry ...

In recent years, technology regulation has sparked heated debate worldwide. Critics often argue that government-imposed restrictions stifle innovation, harm competitive advantage and slow the pace ...

FDA clears iRhythm's first 510(k ... By extending its current 14-day wear time closer to the 30-day benchmark of rival devices and enabling the system to function as an event monitor if prior ...

By Christina Jewett The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division. Dr. Tarver will face ...