Search Results for recalls

Showing 1 – 25  of 25

Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018) By Nick Paul Taylor - Published 16 January 2018

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, black triangle, device data, recalls

Device Recalls in 2017: Making Sense of the Numbers By Michael Mezher - Published 10 January 2018

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices

Tags: Recalls, Corrections, Removals, Class I Recall

House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal By Zachary Brennan - Published 16 February 2017

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

Categories: US, FDA, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: DeLauro, mandatory drug recall, FDA authority, drug recalls, homeopathic

CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

Categories: News, US, CDRH, Compliance, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: device recalls, FDA recalls, recall coordinators

Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016) By Nick Paul Taylor - Published 29 November 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug recalls, medicinal cannabis, antidiabetic

Health Canada Issues New Medical Device Recall Guide By Michael Mezher - Published 04 November 2016

Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR), replacing the agency's 2011 guidance.

Categories: News, Canada, Health Canada, Compliance, Distribution, Medical Devices, Product withdrawl and retirement

Tags: Medical Device Recalls

Adverse Events Push FDA to Recall Portable Oxygen Systems By Zachary Brennan - Published 29 March 2016

The US Food and Drug Administration (FDA) on Tuesday announced that it’s calling on consumers, businesses, schools and health providers to immediately stop using OxySure Therapeutics’ Portable Emergency Oxygen System, Model 615, after the company’s voluntary recall from last year was ineffective.

Categories: News, US, FDA, Crisis management, Labeling, Manufacturing, Medical Devices, Product withdrawl and retirement

Tags: OxySure, portable oxygen systems, FDA device recalls

Bacterial Infections Push FDA to Recall Certain Endoscope Washers By Zachary Brennan - Published 13 November 2015

The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection.

Categories: News, US, FDA, Compliance, Crisis management, Medical Devices, Product withdrawl and retirement, Quality, Regulatory intelligence

Tags: endoscope, bacterial infection, duodenoscope, FDA recalls

Medical Device Recalls Plunge to Near-Record Lows in First Quarter of 2015 By Alexander Gaffney, RAC - Published 06 April 2015

The number of medical device recalls appears to have plunged during the first quarter of 2015, a review of the US Food and Drug Administration's (FDA) data by Regulatory Focus has revealed.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: Medical Device Recalls, openFDA, Recall Classification

Up in Smoke: Canadian Regulators Find Pot too Potent By Michael Mezher - Published 13 February 2015

A licensed medical marijuana producer in Canada has issued a recall for its pot-based product, saying some batches of it are too strong.

Categories: News, Canada, Health Canada, Compliance, Government affairs, Labeling, Manufacturing

Tags: Medical Marijuana, Recalls, Labeling

Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns By Alexander Gaffney, RAC - Published 11 August 2014

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Recall, Drug Recalls, FDA Recalls, Drug Recalls Increasing, Class I Recall, Class II Recall, Class II Recall

FDA Wants to Make Product Recalls Easier to Track By Alexander Gaffney, RAC - Published 17 July 2014

A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Product withdrawl and retirement

Tags: openFDA, Application programming Interface, API, Recalls

Device Recalls Surge While Pharma Offers Mixed News in Latest Recall Report By Alexander Gaffney, RF News Editor - Published 12 November 2013

Categories: US, FDA

Tags: Stericycle, ExpertRECALL, Recall, Latest News, pharmaceutical, recalls, drug, medical device

Pharmaceutical, Device Recalls Spike in Second Quarter, Led by Compounding and Global Trends By Alexander Gaffney, RF News Editor - Published 20 August 2013

Categories: US

Tags: Stericycle, Latest News, pharmaceutical, recalls, drug, medical device

Report Shows Big Increase in Pharmaceutical Recalls Led by Compounding Pharmacy Troubles By Alexander Gaffney, RF News Editor - Published 16 May 2013

Tags: Stericycle, Report, Recall, Latest News, pharmaceutical, recalls, drug, medical device

FDA Draft Guidance Aims to Clarify Difference between Recalls and Removals By Alexander Gaffney, RF News Editor - Published 22 February 2013

Categories: FDA, CDRH

Tags: recalls, medical device

Report: Repeat Recalls by Device Companies at 30-Month High By Alexander Gaffney, RF News Editor - Published 14 February 2013

Categories: FDA

Tags: Stericycle, Latest News, pharmaceutical, recalls, drug, medical device

India's CDSCO Releases Proposed Changes to Recall System with Focus on Timelines By Alexander Gaffney, RF News Editor - Published 01 November 2012

Categories: India, CDSCO

Tags: Draft Guideline, Latest News, guideline, recalls

Report: Recall Trends Generally Flat Through First Half of Year By Alexander Gaffney - Published 21 August 2012

Categories: FDA

Tags: Stericycle, Latest News, pharmaceutical, recalls, drug, medical device

FDA Looking to Overhaul Compliance Approach By Alexander Gaffney - Published 06 August 2012

Categories: FDA, Compliance

Tags: Roh, The Case for Quality, QSR, Latest News, recalls, medical device

Revised FDA Enforcement Report Stresses Clarity, Data Accessibility By Alexander Gaffney - Published 21 June 2012

Categories: FDA, CDER

Tags: Enforcement Report, Latest News, pharmaceutical, recalls, drug, pilot program

FDA Plans Major Overhaul of Recall Reporting By Alexander Gaffney - Published 08 June 2012

Categories: FDA

Tags: APIs, Enforcement Report, Transparency, Latest News, data, Changes, recalls, information, pilot program

Study: FDA Recall Communication System Ineffective, Poorly Designed By Alexander Gaffney - Published 06 June 2012

Categories: FDA

Tags: Dear Doctor Letter, Recall Alert System, Archives of Internal Medicine, Class I, MedWatch, Latest News, recalls, study

FDA Looking to Speed up Public Notification of Recalls By Alexander Gaffney - Published 01 June 2012

Categories: FDA, CDER

Tags: Enforcement Report, Latest News, pharmaceutical, recalls, drug, pilot program

Proposed Legislation Would Allow for Conditional Clearance of Medical Devices By Alexander Gaffney - Published 01 June 2012

Tags: Conditional Approval, Braley, Legislation, House, Latest News, Senate, Bill, Congress, Medical Device Patient Safety Act, recalls, medical device