MyChesCo on MSN1h
FDA Unveils Life-Changing Drug, Urgent Device Alert, and Revolutionary Tech to Protect Your Health
The U.S. Food and Drug Administration (FDA) has announced a series of critical updates this week, reflecting its ongoing ...
News-Medical.Net19h
Healthcare groups urge FDA to act on compounding regulations after GLP-1 medicine shortages
Today, the Obesity Action Coalition (OAC) and The Obesity Society (TOS) sent a letter to the U.S. Food & Drug Administration (FDA), along with more than 20 leading organizations and providers across ...
Alnylam's Amvuttra Secures FDA Approval For Expanded Use For Rare Heart Disease, Stock Jumps
The approval expands the indication for Amvuttra, which now becomes the first and only therapeutic approved by the FDA for ...
Health Affairs2d
Fosamax Lawsuit: The Importance Of State Duties To Warn Of Drug Dangers
Fosamax further defines the obligation of drug manufacturers to present clear, unambiguous, and accurate information to the ...
BioWorld4d
FDA hits Q’Apel Medical with warning for design changes to Hippo
The U.S. FDA warning letter to Q’Apel Medical Inc., of Fremont, Calif., lists several deviations from the regulation, but the ...
FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Medical Design & Outsourcing5d
De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
Med Device Online6d
Key QMS Considerations For Your Medical Device Startup
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...