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Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017) By Nick Paul Taylor - Published 11 July 2017

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

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

Tags: Asia Regulatory Roundup, J&J, Boehringer Ingelheim

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: J&J, Pfizer, Allergan, combination products and FDA

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 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: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

Dr. Khoo Teng Chuan, Co-Chair of the RAPS Pan Asia Advisory Committee, Dies at 56 By Zachary Brennan - Published 30 September 2015

Dr. Khoo Teng Chuan, a leader and expert in the pharmaceutical and medical device sectors across Asia, passed away on Tuesday at the age of 56.

Categories: News, Asia, GHTF, IMDRF

Tags: Singapore, Dr Khoo Teng Chuan, J&J, Singapore Clinical Research Institutes

J&J’s Regulatory Executives Groomed as Business Leaders By Zachary Brousseau - Published 09 December 2014

J&J’s innovative AcceleRAte program grooms regulatory professionals to be the company’s future business leaders.

Categories: Under RAPS, Career Development

Tags: Johnson & Johnson, J&J, business, leadership

J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk By Alexander Gaffney, RAC - Published 05 March 2014

Categories: US, FDA

Tags: Sun Pharma, Orange Book, Janssen, J&J, Lipodox, Doxil, RLD, ANDA, Citizen Petition, Latest News, NDA

Regulators Ask: Is FDA's Generic Drug Submission Process Broken? By Alexander Gaffney, RAC - Published 22 January 2014

Categories: US, FDA

Tags: Generic Drug, 505(j), ANDA, Latest News, pharmaceutical, reform, drug

EU, US Regulators Team up to take on Generic Pharmaceutical Manufacturers By Alexander Gaffney, RF News Editor - Published 18 December 2013

Categories: US, EMA, FDA

Tags: Generic Drug, 505(j), Generic, ANDA, pharmaceutical, Inspection, drug, EU

J&J to Pay $2.2 Billion for Off-Label Marketing of Risperdal in Third-Largest Settlement Ever By Alexander Gaffney, RF News Editor - Published 04 November 2013

Categories: US, DOJ

Tags: Corporate Integrity Agreement, CIA, Risperdal, Janssen, J&J, Settlement, Fine, Latest News

FDA Announces Bevy of Sterility-Related Recalls By Alexander Gaffney, RF News Editor - Published 09 September 2013

Categories: US, FDA

Tags: Sterility, McNeil, J&J, Recall

J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece By Alexander Gaffney, RF News Editor - Published 19 June 2013

Categories: US, FDA

Tags: Untitled Letter, Janssen, J&J, Xarelto, Johnson & Johnson, Latest News, fair balance

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

Approval of New J&J Diabetes Drug Reflects Regulators' Ongoing Safety Concerns By Alexander Gaffney, RF News Editor - Published 01 April 2013

Categories: US, FDA, CDER

Tags: Diabetes, J&J

FDA Now Able to Temporarily Approve Generic Drugs Using Different Label than RLD By Alexander Gaffney, RF News Editor - Published 14 February 2013

Categories: FDA

Tags: Generic Drug, MAPP, 505(j), RLD, ANDA

Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages By Alexander Gaffney, RF News Editor - Published 01 February 2013

Categories: FDA, Manufacturing, Quality

Tags: Ben Venue, J&J, Consent Decree, Shortages, Johnson & Johnson, Latest News, Drug Shortages, cGMP

Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants Published 29 January 2013

Tags: J&J, metal-on-metal, Johnson & Johnson, DePuy

Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute By Alexander Gaffney, RF News Editor - Published 18 October 2012

Categories: FDA

Tags: Sun Pharma, Ben Venue, Janssen, J&J, Lipodox, Doxil, Shortages, Latest News, Drug Shortages

WSJ: Johnson & Johnson Looks to Ease Drug Shortages through Shared Manufacturing Plan By Alexander Gaffney - Published 09 October 2012

Tags: Ben Venue, J&J, Lipodox, Doxil, Shortages, Johnson & Johnson, Latest News, Drug Shortages, pharmaceutical

J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner By Alexander Gaffney - Published 05 October 2012

Tags: Shareholder, Risperdal, Janssen, J&J, Kessler, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

J&J to Pay Millions in Marketing Lawsuit Published 31 August 2012

Tags: Johnson, Risperdal, J&J, Settlement, Lawsuit, Latest News

GPhA: 505(j) Provisions Saved US $1 Trillion Since 2002 By Alexander Gaffney - Published 06 August 2012

Categories: Drugs

Tags: One Trillion Dollars, Savings, 505(j), GPhA, ANDA, Latest News, Generics

Reports: J&J Reaches Agreement to Settle Lawsuit Over 'Tsunami of Regulatory' Problems By Alexander Gaffney - Published 13 July 2012

Tags: Shareholder, J&J, Settlement, Lawsuit, Johnson & Johnson, Latest News, regulatory

J&J Warns Physicians About Counterfeit Medical Device By Alexander Gaffney - Published 14 June 2012

Tags: Notification, Dear Healthcare Professional, Ethicon, J&J, Counterfeit, Latest News, medical device

Reports: Johnson & Johnson to Pay $2.2 Billion to Settle Risperdal Marketing Probe By Alexander Gaffney - Published 11 June 2012

Categories: DOJ

Tags: $2.2 billion, Prosecutors, Risperdal, J&J, Antipsychotic, Settlement, Lawsuit, Fine, Johnson & Johnson, Latest News, regulatory

J&J Announces Planned Cessation of Vaginal Mesh Sales By Alexander Gaffney - Published 06 June 2012

Categories: FDA

Tags: Lawsuits, Regulatory Approval, Ethicon, Vaginal Mesh, J&J, Unapproved, Johnson & Johnson, Latest News, Sales