FDA
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Hospitals
FDA’s Program Alignment Addresses New Regulatory Challenges
By: Margaret A. Hamburg, M.D. Over the last year, a group of senior FDA leaders, under my direction, were tasked…
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Biologics
Integra Gets Thumbs Up on FDA Reinspection of Puerto Rico Plant
The FDA completed its reinspection of Integra Life Sciences’ Añasco, Puerto Rico, manufacturing facility on Sept. 30, finding all issues…
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FDA Invents: How technology transfer gets FDA inventions from lab to marketplace
By: Alice Welch, Ph.D. If you think the term “government invention” is an oxymoron—well, think again. You may be surprised…
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Hospitals
Judge tosses FDA whistleblowers lawsuit
October 3, 2014 by Brad Perriello A federal judge in Washington tosses a lawsuit filed by FDA whistleblowers who accused…
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Hospitals
FDA launches cybersecurity initiative
October 1, 2014 by Alexander Soule The FDA asks medical device manufacturers to submit documentation about controls they have in…
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Biologics
Court rules that FDA cannot rescind 510(k)s without notice and comment procedures
By Varun Saxena The FDA’s powers to reclassify devices were restricted by a federal appeals court ruling that said the…
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Hospitals
Studies criticize U.S. medical device approval process
(Reuters Health) – Information on the safety and effectiveness of medical devices before and after they are cleared by U.S.…
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Biologics
Appeals court vacates FDA’s rescission of ReGen’s MenaFlex implant
September 29, 2014 by Brad Perriello A federal appeals court vacates the FDA’s decision to rescind its 510(k) clearance for…
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Hospitals
December 12, 2014: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Center Date Time Location CDRH December 12, 2014 8:00 a.m. – 6:00 p.m. Holiday Inn Washington-College Park 10000 Baltimore Ave.…
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Hospitals
FDA to Test out New Standardized Medical Device Labels in Proposed Study
By Alexander Gaffney, RAC The US Food and Drug Administration (FDA) plans to study whether it could standardize device labeling…
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Hospitals
Groups press FDA to encourage medical-device registries
By Jaimy Lee The U.S. healthcare system trails behind other developed countries in tracking the performance of medical devices through registries,…
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Hospitals
FDA USER FEES DROP 3% FOR 2015
Walter Eisner • Thu, August 7th, 2014 FDA medical device user fees are going down by 3%. Medical device companies…
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Uncategorized
FDA Researchers Build Partnerships to Advance Innovations
By: David G. White, Ph.D. Last week, FDA scientists and researchers presented more than 160 abstracts at the 4th Annual Food…
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Uncategorized
Former FDA head says biotech business model ‘is basically falling apart’
Don Seiffert BioFlash Editor-Boston Business Journal A former head of the U.S. Food and Drug Administration who will help lead a…
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Hospitals
52 spine, orthopedic devices receive FDA 510(k) clearance in July
Written by Laura Dyrda The Food and Drug Administration granted 52 orthopedic- and spine-related device exemptions in July. 1. Choice Spine Lumbar Spacer…
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