Detailed briefing for FDA on the complications of CoCr arthroprosthetic Metallosis – Dr Stephen Tower
Attached is the detailed briefing notes (PDF) for Dr Towers recent presentation to the FDA. Tower briefing to Raj Rao191110
Attached is the detailed briefing notes (PDF) for Dr Towers recent presentation to the FDA. Tower briefing to Raj Rao191110
Background: The FDA recently announced two days of hearings of the Immunology Advisory Panel relating to the auto immune and …
NY Times By JEANNE LENZERJAN. 13, 2018 When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to …
Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance Program Was Unlawful | The Dissenter. Congressional Investigation Finds FDA’s Unprecedented Whistleblower Surveillance …
Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …
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 …
Cardiologist William Maisel Arrested In Prostitution Sting Operation – Forbes. Larry Husten, Contributor I’m a medical journalist covering cardiology news. …
F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants By BARRY MEIER Published: January 16, 2013 Source: New York Times …
FDA Asks Judge to Dismiss Spying Suit Filed by Employees – Businessweek. Bloomberg News FDA Asks Judge to Dismiss Spying …
A presentation at a Food and Drug Administration (FDA) meeting about metal-on-metal hip implants covered the life-threatening corrosion that occurs …
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …
FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …
FDA SpyGate — New Revelations Challenge The New York Times Investigation of Agency “Enemies List,” Raise More Questions About the …
Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …
Rival Tried to Block FDA Approval of Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device | NewsInferno. Rival Tried to …
FDA Employee Surveillance May Indicate the Agency Has Lots to Hide | Top Secret Writers. FDA Employee Surveillance May Indicate …
Protection to paranoia for FDA’s surveillance program | Editorials | Tri-CityHerald.com. Protection to paranoia for FDA’s surveillance program Published: July …
FDA shouldn’t be spying on whistle-blowers – Tampa Bay Times. FDA shouldn’t be spying on whistle-blowers In Print: Saturday, July …
I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …
Troubled Hip Implants Require Additional Patient Monitoring | Goldberg & Osborne. Troubled Hip Implants Require Additional Patient Monitoring JULY 20, …
Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …
FDA surveillance operation draws criticism from lawmakers | Reuters. FDA surveillance operation draws criticism from lawmakers WASHINGTON | Sun Jul …
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 …
Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …
Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …
Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …
Earlsview Over the year since I set up Earlsview as part of my “anger management” the site has had nearly …
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
FDA Faces Daunting Task as Health Apps Multiply | Sci-Tech Today. FDA Faces Daunting Task as Health Apps Multiply By …
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA. MoMs Hips a Grinding Dilemma for Hospitals, Doctors, FDA Cheryl Clark, …
June 28 2012 – Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 2 Click the link …
June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …
FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …
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 …
FDA, Summary Minutes, Meeting of the Orthopedic and Rehabilitation Devices Advisory Panel, Open Session, Hilton Washington D.C. North, Gaithersburg, MD, …
I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …
FDA Cuts a Deal to Fast Track Drugs and Devices. By MERRILL GOOZNER, The Fiscal Times May 11, 2012 Over the …
Health Canada Recommends Patients to Be Careful About Metal-On-Metal Hips | French Tribune. Submitted by Nimisha Sachdev on Thu, 05/10/2012 …
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …
By John Gever, Senior Editor, MedPage Today Published: March 12, 2012 Revision of total hip replacement surgery within five years …
(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …
BBC News – Surgeons call for end to metal hip replacements. Surgeons call for end to metal hip replacements By …
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 …
Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …
FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …
China Kanghui Holdings Receives FDA Approvals for Hip and Knee Systems – MarketWatch. Jan. 6, 2012, 7:31 a.m. EST China …
Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …
Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …
Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …
Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …
FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …
What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …
Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …
US Drug Watchdog Says It’s Urgent They Identify All Recalled DePuy ASR Hip Implant Recipients & Applauds NBC News For …
Remedy Is Elusive as Metallic Hips Fail at a Fast Rate By BARRY MEIER Source New York Times Published: September …
Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …
The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …
Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …
Hip Implant Complaints Surge, Even as the Dangers Are Studied By BARRY MEIER and JANET ROBERTS Source: The New York …
Orthopedic companies settle DOJ probe, face SEC scrutiny; Medtronic loses a patent suit to Johnson & Johnson, releases new spinal …
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011 Source: Medical Design Online For the first …
IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham August 15, 2011 Source: Cardiovascular Business David …
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …
Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …
Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …
Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …
Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …
Hips and Hip Replacements: What you need to know by Thomas W. Miller Ph.D. ABPP, Staff Writer Published Online Aug …
How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …
How ‘Bout Smith & Nephew posted by Karen on 02 Aug 2011 at 6:34 pm All this data refers to …
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …
August 03, 2011 10:07 AM Eastern Daylight Time NMS Labs Announces Its New Chromium and Cobalt Test to Assist the Medical …
FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …
Hip implant class action grows David Jean From The Advertiser August 01, 2011 12:00AM An orthopedic surgeon studies a patient’s …
Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …
Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …
7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …
Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The government’s system for regulating many medical …
Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …
Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …
Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …
Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …
Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …
Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …
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 & …
‘Metal on metal’ hip implants leave some recipients in pain, at risk By Anita Creamer; The Sacramento Bee – click …
FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …
Kohl: FDA’s Post-Market Review of Hip Implants Welcome, But More Scrutiny Needed [Targeted News Service] WASHINGTON, May 24 — The …
I had the privilege of getting some great questions from Howard last night and I thought that they, along with …
FDA Letter to: Smith & Nephew Orthopaedics Gmbh 12/21/10 Department of Health and Human Services Public Health ServiceFood and Drug …
Fallout from DePuy ASR Hip Implant Recall Felt Globally Date Published: Monday, January 10th, 2011 The impact of the DePuy …
DePuy Hip Implant Lawsuit Says Company Ignored Defects Date Published: Friday, January 14th, 2011 Five Chicago residents have filed a …
What the FDA has to say About Metal on Metal Hips FDA Website – click here Metal-on-Metal Hip Implants Hip …
FDA Metal-on-Metal Hip Implant Website Details Risks Date Published: Friday, February 18th, 2011 The U.S. Food & Drug Administration (FDA) …
Texas DePuy Hip Implant Lawsuit Claims Metal Contamination Date Published: Tuesday, March 29th, 2011 Another defective DePuy hip implant lawsuit …
DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …
FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …
Makers of Metal-on-Metal Hip Implants Ordered to Conduct Safety Studies Date Published: Wednesday, May 11th, 2011 Federal health regulators have …
Zimmer Durom Cup Named in New Metal-on-Metal Hip Implant Lawsuit Date Published: Wednesday, July 6th, 2011 A new lawsuit involving …
What Caused The Stryker Trident Hip Replacement System Recall? Posted on July 4, 2011 by Rottenstein Law Group Stryker Corporation …
From the FDA Database – the DePuy ASR 510K Traditional Application file – confidential parts greyed out Download here – …
Final results for year ended December 2010 22 March 2011 Source http://www.coringroup.com/news.php?o=98 Corin Group PLC has today published its full year …
DePuy ASR Hip Replacement Recall Lawsuit This is a very informative Video – MUST Watch… Technorati Tags: FDA, …
New DePuy President – New DePuy Hip Challenges J. Cooper Carlisle | July 2nd, 2011 | Posted in Depuy Hip …
Clinical Fallout – Hip Resurfacing – The Corin Involvement This YouTube video clip from the very respected McMinn Centre in …
Sadwin – Did Not See The Smith & Nephew Guide pre-op – Neither Did I… Actually My Surgeon told me …
DePuy Lawsuit Hip Problems You Should Not Ignore At times, we do not know the underlying problems that will affect …