Simplifying Global Compliance
The White House is proposing an 8 percent increase in FDA funding in fiscal 2015, but CDRH won’t see much of a boost. Read More
Devicemakers will be able to distribute a wider range of clinical practice guidelines and medical textbooks to physicians under loosened FDA restrictions for off-label promotion. Read More
The Centers for Medicare & Medicaid Services should ensure that patients receiving care through the new Accountable Care Organizations are not denied innovative treatments due to cost, AdvaMed says in comments to CMS Administrator Marilyn Tavenner. Read More
The current kerfuffle around online direct-to-consumer genetic testing service 23andMe.com came out of “a perfect storm” that led to the widespread marketing of such tests, experts say. Read More
Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More
CDRH has updated its Export Certification and Tracking System, allowing users to now make changes to applications prior to review. Read More
An FDA action plan on subgroup analysis, currently in the works, could make device trials excessively large and expensive by imposing unnecessary requirements, AdvaMed warns. Read More
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