Search Results for Abbott

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Abbott Recalls 465,000 Pacemakers for Cybersecurity Patch By Michael Mezher - Published 30 August 2017

Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices.

Categories: News, US, FDA, Medical Devices

Tags: Cybersecurity, Abbott, St. Jude Medical

Asia Regulatory Roundup: Indian Watchdog Probes Allegations Roche Tried to Influence Regulators (2 May 2017) By Nick Paul Taylor - Published 02 May 2017

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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Medtronic, Abbott, Roche, Herceptin, biosimilars

FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds

Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016) By Nick Paul Taylor - Published 18 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Labeling, Quality

Tags: Asia Regulatory Roundup, GSK, Abbott, data management

A Brighter Future for Regulatory Professionals Published 15 December 2015

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China.

Categories: Features, Asia, CFDA, Government affairs, Nutritional and dietary supplements

Tags: Abbott, Food regulations

Asia Regulatory Roundup: India Looks to Join Pharma Inspection Scheme (15 September 2015) By Nick Paul Taylor - Published 15 September 2015

The Indian commerce ministry is ramping up its attempts to convince the industry of the merits of joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme.

Categories: CDSCO, CFDA, MFDS, TGA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: India, South Korea, Samsung, PIC/S, DCGI, Abbott, cough syrup

Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking By Stewart Eisenhart, Emergo Group - Published 22 October 2014

The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.

Categories: News, Oceania, TGA, In vitro diagnostics, Medical Devices, Submission and registration

Tags: CE Marking, Tony Abbott

Identical Problems Prompt Second Major Warning about Diabetes Testing Device in Single Month By Alexander Gaffney, RF News Editor - Published 15 April 2013

Tags: Abbott, J&J, Recall, medical device

Under Fire, Abbott Suspends Marketing Program in India Published 17 October 2012

Categories: India

Tags: Prescribes, Abbott, Gifts, Doctors, Physicians, Latest News, marketing

Abbott Hit with $1.5 Billion Fine for Off-Label Marketing By Alexander Gaffney - Published 03 October 2012

Categories: DOJ

Tags: $1.5 billion, Depakote, Abbott, Fine, Off-label, Latest News, marketing

Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing By Alexander Gaffney - Published 08 May 2012

Categories: Compliance

Tags: Corporate Integrity Agreement, CIA, Anti-Seizure, $1.5 billion, Depakote, Abbott, Fine, Off-label, Latest News, marketing

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations By Alexander Gaffney - Published 08 May 2012

Tags: Negotiating, Amgen, Abbott, AstraZeneca, Pfizer, Merck, E&C, Energy and Commerce Committee, PhRMA, House, negotiation, Latest News, Obama, PPACA, information

Study Calls for Changes to FDA Treatment of Generic Competition By Alexander Gaffney - Published 11 April 2012

Categories: FDA

Tags: 505(b)(2), TriCor, Abbott, Competition, Substitution, Generic, Latest News, pharmaceutical, study, drug