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 ...
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", ...
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 ...
Medical Device Network on MSN8d
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Nature13d
Drug regulation articles from across Nature Portfolio
We analysed new anticancer drug indications approved by the FDA and EMA between 2020 and 2023 using the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale quality-of-life ...
Canada14d
Drug shortages in Canada: Regulations and guidance
The Food and Drug Regulations (FDR) contain provisions that help to safeguard ... The last of these was the Second Interim Order respecting drugs, medical devices and foods for a special dietary ...
C&EN15d
FDA nominee Marty Makary outlines vision for improving public health
Marty Makary, President Donald J. Trump’s nominee to lead the US Food and Drug Administration, sailed through questioning during a Senate confirmation hearing on March 6, paving the way for the ...
Roll Call15d
Makary tells Senate panel he plans to review FDA job cuts
President Donald Trump’s pick to lead the Food and Drug Administration vowed Thursday to review the Trump administration’s sweeping job cuts at the agency. “I have not been involved in any ...
BioSpace16d
MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson’s Disease
Rx-only medical device with the U.S. Food and Drug Administration (FDA). The company unveiled the system’s brand name: Movive ™. “Movive leverages the well-researched power of rhythmic auditory ...
Business Times16d
Singapore to get new regulations to tackle online sale of non-compliant mobility devices
REGULATIONS against online marketplace platforms and retailers selling non-compliant active mobility devices will be introduced here, said Senior Parliamentary Secretary for Transport Baey Yam Keng on ...
The Australian18d
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor is executing a modular review process with the FDA, whereby modules covering ... CE mark certification under new European Medical Device Regulation. IMR is working to improve cardiac ...
NHS England19d
Medical devices and digital tools
These are categorised differently into 4 main groups. Detailed information aimed at suppliers on how to classify medical device and what regulations are required can be found at the following links: ...