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FDA posts final guidance on remanufacturing medical devices
MedTech Dive via Yahoo Finance· 3 days agoNearly three years after publishing draft guidance, the FDA has changed the title and added a...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
WKBT La Crosse· 4 days agoAs late as the 1940s, the US Centers for Disease Control and Prevention said Thursday in a...
FDA says hundreds injured due to software glitch connecting insulin pumps to iPhones
WFTV via Yahoo News· 22 hours agoEarlier this year, there was a glitch in the software that connects the “t:slim X2″ insulin pump to...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
ABC Action News Tampa Bay· 1 day agoThe World Health Organization says malaria is a significant global health issue, with 249 million...
Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting...
The National Law Review· 5 days agoAt the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR)...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 3 days agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
FDA chief says feds are preparing for low probability of bird flu moving to humans
Source New Mexico via Yahoo News· 4 days agoFood and Drug Administration said at a congressional hearing Wednesday the agency is preparing for...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 7 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of Adolescents with...
Benzinga· 8 hours agoRegeneron Pharmaceuticals, Inc. REGN and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...
Fulcrum Therapeutics Q1 2024 Earnings: Misses Analyst Net Income Projections Amid Strategic ...
GuruFocus.com via Yahoo Finance· 22 minutes agoMarket and Future Outlook The biopharmaceutical landscape for rare genetic diseases is both...