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Filtering on: "topics product withdrawl and retirement"

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FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances By Zachary Brennan - Published 10 January 2017

The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances.

Categories: News, US, FDA, WHO, Drugs, Government affairs, Product withdrawl and retirement

Tags: cannabis, marijuana, controlled substances, DEA

Medical Device Manufacturer Pleads Guilty to Misbranding and Agrees to Pay $36M By Zachary Brennan - Published 11 November 2016

Pennsylvania-based medical device manufacturer Biocompatibles Inc., a BTG subsidiary, pleaded guilty earlier this week to misbranding its embolic device used to treat liver cancer, among other diseases, and will pay more than $36 million due its illegal conduct, the Justice Department (DOJ) said. 

Categories: News, US, DOJ, FDA, Advertising and Promotion, Crisis management, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: Biocompatibles, misbranded medical devices, drug delivery, chemotherapy, LC Bead, BTG

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

FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database By Zachary Brennan - Published 25 October 2016

As part of efforts to reduce an increasing number of adverse events from home-use medical devices, FDA is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.

Categories: News, US, FDA, Labeling, Medical Devices, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: home-use medical devices, new FDA proposed rule, FDA rules

FDA Amends Definition of Custom Device By Zachary Brennan - Published 11 October 2016

The Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA).

Categories: News, US, CDRH, Compliance, Government affairs, Medical Devices, Product withdrawl and retirement, Project management, Quality

Tags: custom medical device, device regulations, premarket notification, FDA final rule

Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer By Zachary Brennan - Published 30 August 2016

Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable.

Categories: News, China, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing, Product withdrawl and retirement, Quality

Tags: Chinese API manufacturing, FDA warning letters

Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing By Zachary Brennan - Published 25 August 2016

Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain.

Categories: News, US, FDA, Drugs, Government affairs, Postmarket surveillance, Product withdrawl and retirement

Tags: opioid, off-label marketing, pharmaceutical lawsuits, Insys Therapeutics

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

FDA: Toxicity Seen in Fatal French Study Does Not Extend to Other FAAH Inhibitors By Zachary Brennan - Published 12 August 2016

The U.S. Food and Drug Administration (FDA) on Friday said that after reviewing the safety information of a first-in-human clinical trial in Rennes, France that resulted in the death of one healthy volunteer and the hospitalization of five others in January, the agency found that the toxicity exhibited in the trial does not extend to other drugs in the class, known as fatty acid amide hydrolase (FAAH) inhibitors.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Government affairs, Product withdrawl and retirement, Regulatory intelligence

Tags: Bial, Biotrial, France Phase 1 study, clinical trials, FAAH inhibitors

Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority By Zachary Brennan - Published 12 August 2016

A lack of quality assurance (QA) oversight, a refusal of an inspection by the US Food and Drug Administration (FDA) and a failure to commit to any corrective actions regarding current good manufacturing practice (CGMP) violations observed on an FDA inspection landed a Chinese company an FDA warning letter, and a statement of non-compliance and a ban for two Indian companies recently.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement, Quality

Tags: China drug manufacturing, Indian APIs, statement of noncompliance, warning letter

Florida CMO Recalls All Lots of Liquid Drugs Due to Bacteria Outbreak By Michael Mezher - Published 10 August 2016

Contract manufacturing organization PharmaTech on Monday announced a voluntary recall of all of its liquid drug formulations made at its Davie, Florida facility over a 10-month period after being linked to a multi-state Burkholderia cepacia outbreak.

Categories: News, US, FDA, Drugs, Medical writing, Product withdrawl and retirement, Quality

Tags: Contract manufacturing organization, PharmaTech, Burkholderia cepacia, B. cepacia, Docusate sodium, Recall

Regulatory Recon: Obama to Sign Opioids Bill; Woodcock on 30 Years at FDA (14 July 2016) By Zachary Brennan - Published 14 July 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EC, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Product withdrawl and retirement

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

New Report Calls on FDA to Clarify Use of Real-World Evidence By Zachary Brennan - Published 23 June 2016

As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: real world evidence, FDA Commissioner, Robert Califf, Patrick Soon-Shiong, Duke University

Faulty Filter Prompts Recall of Leukocyte Reduction Device By Michael Mezher - Published 23 June 2016

The US Food and Drug Administration (FDA) on Thursday warned healthcare providers that a faulty filter in recently distributed lots of Haemonetics' Leukotrap RC System can result in higher than acceptable leukocyte counts in blood used in transfusions.

Categories: News, US, CBER, Blood, Product withdrawl and retirement

Tags: Haemonetics, Leukotrap

Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA By Zachary Brennan - Published 27 May 2016

Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Compliance, Product withdrawl and retirement

Tags: Sanofi, Mylan, PhRMA, GPhA, biosimilars, BPCIA

Petition Calls on FDA to Pull All Fluoride Supplements From the Market By Zachary Brennan - Published 18 May 2016

The Fluoride Action Network (FAN) and the International Academy of Oral Medicine & Toxicology (IAOMT) are calling on the US Food & Drug Administration (FDA) to expedite the removal from the market all unapproved, unsafe, unnecessary and ineffective sodium fluoride-containing drops, tablets and lozenges sold for the intended purpose of preventing tooth decay.

Categories: News, US, FDA, Nutritional and dietary supplements, Product withdrawl and retirement

Tags: fluoride, fluoride supplements, Walmart, Walgreens, CVS, Rite Aide

Asia Regulatory Roundup: China Fast Tracks Hepatitis C, Cancer Drug Approvals (26 April 2016) By Nick Paul Taylor - Published 26 April 2016

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

Categories: News, Asia, CFDA, Drugs, Government affairs, Medical writing, Product withdrawl and retirement, Quality

Tags: Harvoni, Sovaldi, CFDA inspections, Merck Serono, Sandoz

AbbVie, FDA Withdraw Two Cholesterol Drugs from US Market as Benefits No Longer Outweigh Risks By Zachary Brennan - Published 15 April 2016

The US Food and Drug Administration (FDA) on Friday announced that it’s withdrawing approval of AbbVie’s new drug applications (NDAs) for the cholesterol drugs Advicor (niacin extended-release [ER] and lovastatin) and Simcor (niacin ER and simvastatin) as new research shows the benefits of the drugs no longer outweigh the risks.

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

Tags: cholesterol drugs, Advicor, Simcor, AbbVie

EMA Begins Pharmacovigilance Training Courses By Zachary Brennan - Published 08 April 2016

The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA).

Categories: News, Europe, EC, EMA, MHRA, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: EMA, pharmacovigilance, EudraVigilance

Senate Committee Advances Five More Bills as Part of Medical Innovation Package By Zachary Brennan - Published 06 April 2016

The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.

Categories: News, US, FDA, Biologics and biotechnology, Business Skills, Combination products, Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Packaging, Postmarket surveillance, Product withdrawl and retirement, Reimbursement

Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP

Report Outlines New FDA Device Evaluation System, Coordinating Center By Zachary Brennan - Published 04 April 2016

A national medical device evaluation system planning board, created in part by the US Food and Drug Administration, released a new report on Monday outlining how it plans to develop a national medical device evaluation system (NMDES) and a center to coordinate such efforts.

Categories: News, US, CDRH, Crisis management, Medical Devices, Postmarket surveillance, Product withdrawl and retirement, Research and development

Tags: medical device safety, device safety tracking, national medical device evaluation system, Duke-Margolis Center for Health Policy, FDA

UK, French Regulators Call Out Two Noncompliant Indian Pharma Sites By Zachary Brennan - Published 04 April 2016

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and France’s ANSM (National Agency for Medicines and Health Products Safety) have sent notices of noncompliance to two Indian pharmaceutical companies that restrict the dissemination of their products in Europe.

Categories: News, India, Europe, EC, MHRA, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: MHRA, ANSM, Indian pharmaceutical manufacturing, noncompliant pharmaceutical companies

FTC Sues Drugmakers for Not Marketing Authorized Generics By Zachary Brennan - Published 31 March 2016

The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws.

Categories: News, US, FTC, Compliance, Crisis management, Government affairs, Product withdrawl and retirement

Tags: FTC, no-AG commitments, pay-for-delay, generic entry, exclusivity

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

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