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 …
Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser | MassDevice. March 11, 2013 by Arezu …
Trials Tell Us So Much about the Groupthink of Corporations – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts. …
F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants By BARRY MEIER Published: January 16, 2013 Source: New York Times …
FDA Executives Knew About Plan to Spy on Whistle-Blower Scientists. FDA Executives Knew About Plan to Spy on Scientists August …
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 …
I have posted a few things around here and owe a debt of gratitude to Earl, as do we all. …
Hip implant materials swing sharply to polyethylene | PlasticsToday.com. Hip implant materials swing sharply to polyethylene By Doug Smock Published: …
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, 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, …
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …
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 …
(Reuters) – Consumer Reports, the 76-year-old publication best known for its reviews of automobiles and refrigerators, is trying to galvanize …
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 …
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 …
Rottenstein Law Group Commends Subcommittee Recommendation of Greater Investigation of Metal-on-Metal Hips to Curb Under-regulation at USFDA The Rottenstein Law …
Spike in Metal-on-Metal Hip Implant Complaints May Point to Looming Disaster Date Published: Wednesday, August 24th, 2011 Source; News Inferno …
The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …
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) …
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 & …
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 …
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) …
DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …
Earl's View 