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RAPS Preview: FDA CDRH Director Shuren Talks Priorities
FDA CDRH or Center for Devices and Radiological Health Director Jeff Shuren, MD, JD, will outline the agency's ambitiou [...]
FDA Eases Up a Bit on Enforcement Gas Pedal as Warning Letters Decline
Medical device warning letters and domestic inspections continue to show a slow decline, according to a new report issue [...]
Improving FDA Reviews of Combination Products
The FDA and Intercenter Consultations Just a few short weeks ago, Robert Califf, the US Food and Drug Administration (F [...]
FDA Guidance Answers (Some) Medical Device Cybersecurity Concerns
A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of [...]
FDA Inspectors Leave Calling Cards For Medical Device Manufacturers Nationwide
Our latest round of warning letters emphasize the importance for medical device manufacturers to generate and control ad [...]
FDA Touts Improved IDE Review Stats
Michael Causey, Editor-in-Chief,Association of Clinical Research Professionals Ironically, FDA is sometimes wary of is [...]
