Search Results for heparin

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Chinese Heparin Contamination Questions Return With New FDA Warning Letter By Zachary Brennan - Published 05 July 2017

The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, Chinese heparin, heparin contamination, FDA warning letters

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, China heparin, House E&C, FDA investigations

FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: heparin, warning letter, heparin manufacturers in China

FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers By Zachary Brennan - Published 08 April 2016

Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection.

Categories: News, China, US, CDER, Combination products, Compliance, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Quality

Tags: China drug manufacturing, Chinese heparin, FDA inspections in China, FDA warning letters for Chinese pharma

Congressmen Slam FDA’s Handling of Investigation Into Tainted Chinese Heparin By Zachary Brennan - Published 30 March 2016

Several members of the House Committee on Energy & Commerce are raising new concerns over the US Food and Drug Administration’s (FDA) investigation into intentionally adulterated Chinese heparin that led to the deaths of 149 Americans in 2007 and 2008.

Categories: News, China, US, CFDA, FDA, Active pharmaceutical ingredients, Audit, Compliance, Crisis management, Drugs, Due Diligence, Ethics, Product withdrawl and retirement

Tags: heparin, tainted heparin, FDA and heparin, Chinese heparin manufacturing

Chinese Heparin Sourcing Questions Resurface After ANSM Inspection By Zachary Brennan - Published 01 March 2016

France's National Agency for Medicines and Health Products Safety (ANSM) raised two critical deficiencies over a Chinese pharmaceutical company’s manufacture of heparin, which harkens back to the scandal from 2007 and 2008 when heparin sourced from Chinese manufacturers killed 149 Americans.

Categories: News, China, Europe, EMA, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Manufacturing, Product withdrawl and retirement, Quality, Reimbursement, Research and development

Tags: Heparin manufacturing, Chinese Heparin, ANSM, drug manufacturing deficiencies

Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims By Alexander Gaffney, RAC - Published 14 October 2014

A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from accessing the facility earlier this year, and possibly manufacturing contaminated products.

Categories: News, China, US, FDA, Biologics and biotechnology, Compliance, Ethics, Manufacturing, Quality

Tags: Heparin, Import Alert, Warning Letter

New FDA Guidance Aims to Better Assess Side Effects of Low Molecular Weight Heparins By Alexander Gaffney, RAC - Published 09 April 2014

Categories: US, FDA

Tags: PF4, HIT, LMWH, Heparin, Latest News, immunogenicity, testing, guidance

Legislators Say Acquisition of US Pork Supplier Would Imperil Safety, Availability of Heparin By Alexander Gaffney, RF News Editor - Published 25 July 2013

Categories: US

Tags: Legislators, E&C, Energy and Commerce, Heparin, Letter, Congress

With Eye on Tainted Chinese Heparin Scandal, FDA Finalizes Quality Monitoring Guidance By Alexander Gaffney, RF News Editor - Published 26 June 2013

Categories: China, US, FDA

Tags: Heparin

FDA Plans Multi-Year Investigation Into Rare Side-Effect of Heparin By Alexander Gaffney, RF News Editor - Published 20 June 2013

Categories: US, FDA

Tags: Side Effect, Heparin, research, study, safety

EMA Releases Draft Guideline on Biosimilar Heparin Products By Alexander Gaffney, RF News Editor - Published 01 February 2013

Categories: EMA

Tags: Heparin, biosimilar, guideline

USP Plans to Launch Updated Heparin Standard to Ensure Safety By Alexander Gaffney - Published 23 May 2012

Tags: Version, Updated, Adulterated, Counterfeit, OSCS, Heparin, Standard, Latest News, USP

Chinese Suppliers Tied to Tainted Heparin Published 23 February 2012

Categories: FDA

Tags: supplies, Heparin, Ban, Import, Latest News

Guidance for Industry on Heparin Released by FDA, Bookend to Heparin Scandal By Alexander Gaffney - Published 10 February 2012

Categories: FDA

Tags: OSCS, Heparin, Latest News, draft guidance, API