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Earl's View

Category Archives: FDA

Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful

March 1, 2014

Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful | The Dissenter. Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance …

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How does the FDA ‘approve’ medical products? – Medical News Today

February 22, 2014

Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …

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WaPo eyes FDA access-peddling by academics

October 9, 2013

10:47 AM – October 7, 2013 WaPo eyes FDA access-peddling by academics http://www.cjr.org/the_audit/the_post_watchdogs_big_pharma.php?page=all&print=true At $25,000 a pop, a chance for …

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Cardiologist William Maisel (deputy director for science at the FDA) Arrested In Prostitution Sting Operation – Forbes

January 20, 2013

Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …

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F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants

January 17, 2013

F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants By BARRY MEIER Published: January 16, 2013 Source: New York Times …

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FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek

October 4, 2012

FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek. Bloomberg News FDA Asks Judge to Dismiss Spying …

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FDA Presentation Describes Corrosion of Metal Hip Implants

September 26, 2012

A presentation at a Food and Drug Administration (FDA) meeting about metal-on-metal hip implants covered the life-threatening corrosion that occurs …

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Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process

September 7, 2012

Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …

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FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List”

August 22, 2012

FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …

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Dems urge FDA to boost medtech recall database | MassDevice.com

August 19, 2012

Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …

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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes

August 18, 2012

Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …

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Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno

July 29, 2012

Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …

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FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers

July 29, 2012

FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …

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Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com

July 28, 2012

Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …

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What does the FDA have to Hide? Who do they work for??

July 28, 2012

FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …

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Smith and Nephew BHR: Mr. Smith, his nephew, and the incident involving their missing BHR Modular Head

July 26, 2012

I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …

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Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne

July 23, 2012

Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne. Troubled Hip Implants Require Additional Patient Monitoring JULY 20, …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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FDA surveillance operation draws criticism from lawmakers | Reuters

July 16, 2012

FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …

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POLICE STATE??? F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com

July 15, 2012

F.D.A. Surveillance of Scientists Spread to Outside Critics – NYTimes.com. In Vast Effort, F.D.A. Spied on E-Mails of Its Own …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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Hip implant materials swing sharply to polyethylene | PlasticsToday.com

July 15, 2012

Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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Dr Stephen (Steve) Tower to Join the Earl’sview site – to answer patient questions

July 14, 2012

Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today

July 8, 2012

FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …

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FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier

July 8, 2012

FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …

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MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA

July 8, 2012

MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2

July 8, 2012

June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1

July 8, 2012

June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …

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FDA releases proposed UDI rule; reaction generally positive

July 8, 2012

FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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Meeting of the Orthopaedic and Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems

July 8, 2012

Meeting of the Orthopaedic and  Rehabilitation Devices Advisory Panel June 27-28, 2012 Metal-on-Metal Hip Systems http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM310217.pdf. This is a PDF …

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FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, at 12 (Sept. 8, 2005)

July 8, 2012

FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …

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Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

June 5, 2012

I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …

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FDA Cuts a Deal to Fast Track Drugs and Devices

May 13, 2012

FDA Cuts a Deal to Fast Track Drugs and Devices. By MERRILL GOOZNER, The Fiscal Times May 11, 2012 Over the …

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Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune

May 12, 2012

Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune. Submitted by Nimisha Sachdev on Thu, 05/10/2012 …

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June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

April 27, 2012

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …

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FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra

March 24, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …

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Metal-on-Metal Hips Need Work More Quickly

March 14, 2012

  By John Gever, Senior Editor, MedPage Today Published: March 12, 2012 Revision of total hip replacement surgery within five years …

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Consumer Reports taps ire over bad medical devices

March 14, 2012

(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …

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BBC News – Surgeons call for end to metal hip replacements

March 7, 2012

BBC News – Surgeons call for end to metal hip replacements. Surgeons call for end to metal hip replacements By …

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Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems

March 3, 2012

Metal-on-Metal Hip Implants > Concerns about Metal-on-Metal Hip Implant Systems. Concerns about Metal-on-Metal Hip Implant Systems All artificial hip replacement …

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The Power of the Birmingham Hip Resurfacing – NOT

January 21, 2012

Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …

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FDA warns J&J’s DePuy unit over joint replacements – AlertNet

January 19, 2012

FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …

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China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch

January 7, 2012

China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …

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