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", ...
Health Affairs19h
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 ...
Does the FDA’s future under Trump 2.0 mean innovation or instability? | Opinion
The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
'Watershed moment': Experts call for hyperbaric chamber regulations after child's death
Industry leaders say the government failed to protect Thomas Cooper, 5, from dying in a hyperbaric chamber fire at the Oxford ...
JD Supra7d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
In wake of child's death, industry leaders call for regulation of hyperbaric chambers
Industry leaders say government failed to protect Thomas Cooper from dying in a hyperbaric chamber fire at the Oxford Center ...
Med Device Online4d
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 ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Manila Standard11d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
Medical Design & Outsourcing3d
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 ...
JD Supra28d
Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages
would amend the Food and Drug Regulations and the Medical Devices Regulations under the Food and Drugs Act. In the Regulatory Impact Analysis Statement accompanying the Proposed Regulations ...