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Earl's View

~ News and Views

Earl's View

Category Archives: FDA Review

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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Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice

March 24, 2013

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice. March 11, 2013 by Arezu …

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Does J&J Care About People? Trials Tell Us So Much about the Groupthink of Corporations – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

February 19, 2013

Trials Tell Us So Much about the Groupthink of Corporations – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. …

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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 Executives Knew About Plan to Spy on Whistle-Blower Scientists

August 23, 2012

FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan to Spy on Scientists August …

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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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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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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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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, 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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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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DePuy Exec’s seem to think money comes first – F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com

March 24, 2012

F.D.A. Asked DePuy for Safety Data Just Before Hip Implant’s Phaseout – NYTimes.com. Hip Device Phaseout Followed F.D.A. Data Request …

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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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Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

January 7, 2012

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …

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Howards View on the FDA and Medical Device Failures

January 7, 2012

Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …

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FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline

December 29, 2011

Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …

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FDA seeks to include more women in medical device trials

December 20, 2011

FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …

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Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA

October 24, 2011

Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …

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Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster

August 28, 2011

Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster Date Published: Wednesday, August 24th, 2011 Source; News Inferno …

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The rate at which FDA issues 483s and warning letters is going up, up, up.

August 25, 2011

The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …

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FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices

August 20, 2011

FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011  Source: Medical Design Online For the first …

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IOM chair discusses 510(k) report: origins, findings, response

August 18, 2011

IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham   August 15, 2011 Source: Cardiovascular Business David …

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FDA Loosens Premarket Notification Requirements for 30 Medical Device Types

August 15, 2011

FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …

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Sadwin gets to the heart of the Issues with FDA 510(k)

August 14, 2011

Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …

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FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units

August 13, 2011

Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …

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Medical Devices — Balancing Regulation and Innovation

August 13, 2011

Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …

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IOM Gives FDA The wrong prescription on medical devices & 510(k)

August 7, 2011

  Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …

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Hips and Hip Replacements: What you need to know

August 7, 2011

Hips and Hip Replacements: What you need to know by Thomas W. Miller Ph.D. ABPP, Staff Writer Published Online Aug …

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How Safe Are Medical Devices?

August 5, 2011

How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …

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How ‘Bout Smith & Nephew

August 4, 2011

How ‘Bout Smith & Nephew posted by Karen on 02 Aug 2011 at 6:34 pm All this data refers to …

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Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants?

August 4, 2011

Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …

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New Chromium and Cobalt Test to Assist the Medical Community

August 4, 2011

August 03, 2011 10:07 AM Eastern Daylight Time NMS Labs Announces Its New Chromium and Cobalt Test to Assist the Medical …

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FDA Seeks Public Views on Proposed 510(k) Plans

August 2, 2011

FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …

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Australian TGA – Reforms in the medical devices regulatory framework

July 31, 2011

Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …

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Report: FDA’s Medical Device Approval Process Is Flawed

July 31, 2011

Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …

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510(k) approval process is too big to fail no matter how flawed it may be

July 31, 2011

7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …

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Barry Meier – Approval process for devices blasted

July 31, 2011

Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The govern­ment’s system for reg­u­lating many med­ical …

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Sadwin Comments on Washington Post Article – Letter to Authors

July 31, 2011

Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …

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FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report

July 31, 2011

FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …

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Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process

July 31, 2011

Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …

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Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs

July 30, 2011

Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …

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Report could sway FDA device review process

July 30, 2011

Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …

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FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process

July 30, 2011

Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …

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510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release

July 30, 2011

510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …

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Barry Meier – Study of Medical Device Rules Is Attacked, Unseen

July 29, 2011

Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …

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Why Are Pharmaceutical Companies Paying The FDA?

July 28, 2011

Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …

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Report: IOM review of the FDA 510(k) process due Friday

July 28, 2011

Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …

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History – Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip

July 24, 2011

Smith & Nephew Receives US FDA Approval For Ceramic-On-Ceramic Hip June 25, 2006 By: Victor Rocha Website: http://www.hip-replacement-care.com    Smith & …

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FDA medical device review times to be subject of House hearing

July 23, 2011

FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …

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Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed

July 17, 2011

Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed [Targeted News Service] WASHINGTON, May 24 — The …

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What the FDA has to say About Metal on Metal Hips

July 10, 2011

What the FDA has to say About Metal on Metal Hips FDA Website – click here Metal-on-Metal Hip Implants Hip …

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FDA Metal-on-Metal Hip Implant Website Details Risks

July 10, 2011

FDA Metal-on-Metal Hip Implant Website Details Risks Date Published: Friday, February 18th, 2011 The U.S. Food & Drug Administration (FDA) …

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Senate Hearing on FDA Medical Device Approvals

July 10, 2011

DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …

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