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Filtering on: "topics quality"

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Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017) By Nick Paul Taylor - Published 14 November 2017

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

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Court Bars Philips From Manufacturing, Selling Some Adulterated Defibrillators By Zachary Brennan - Published 01 November 2017

Following its manufacture and distribution of adulterated automatic external defibrillators (AEDs) and Q-CPR meters, which the U.S. Food and Drug Administration (FDA) said put people at risk, US District Judge Denise Casper on Tuesday entered a consent decree of permanent injunction between the US and Andover, MA-based Philips North America LLC and two company officers.

Categories: News, US, DOJ, FDA, Medical Devices, Quality

Tags: Philips, consent decree, defibrillators

MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

FDA Warns Lead-Testing Diagnostics Company By Zachary Brennan - Published 23 October 2017

The US Food and Drug Administration (FDA) on Monday sent a warning letter to Massachusetts-based Magellan Diagnostics, a subsidiary of Meridian Bioscience, finding the company made significant changes to its lead-testing devices without notifying the agency, among other violations.

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

Tags: lead tests, Magellan Diagnostics, Meridian Bioscience

FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation By Michael Mezher - Published 29 September 2017

The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June.

Categories: News, ICH, Biologics and biotechnology, Clinical, Drugs, Quality

Tags: ICH Assembly, Montreal, E8(R1), Pediatric Extrapolation

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion By Zachary Brennan - Published 16 August 2017

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy

Tags: PhRMA, drug advertising and promotion, FDA research

EMA Updates Guidance on Three Post-Authorisation Activities By Michael Mezher - Published 14 July 2017

The European Medicines Agency (EMA) announced Friday it has updated three post-authorisation activity guidance documents, including type II variations, post-authorisation safety studies and quality variations.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Quality, Submission and registration

Tags: Post-authorisation, Post-authorisation safety studies, Quality, Type II Variation

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry By Ajay Babu Pazhayattil, Naheed Sayeed-Desta, Vijayalakshmi Iyer - Published 16 May 2017

This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability.

Categories: Features, Europe, US, FDA, ICH, Biologics and biotechnology, Drugs, Quality

Tags: ICH Q12, Post Approval Change Management Protocol, Quality by Design, QbD

Thailand's Approach to Drug Quality Assurance: Creation of the Green Book By Thanita Patthamajinda, RPh - Published 27 April 2017

This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.

Categories: Features, Asia, Drugs, Quality

Tags: Thailand, Green Book, Quality Assurance

BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products By Zachary Brennan - Published 17 April 2017

Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.

Categories: News, US, CBER, CDER, CDRH, Biologics and biotechnology, Combination products, Drugs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: BIO, AdvaMed, combination product guidance, pre-RFD program

Researchers Link Target Product Profiles to Shorter Review Times By Michael Mezher - Published 17 April 2017

A recent analysis finds that drug and biologic submissions to the US Food and Drug Administration (FDA) that reference a target product profile (TPP) are associated with shorter review times at the agency.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Labeling, Quality, Regulatory strategy, Submission and registration

Tags: Target Product Profile, TPP, Quality Target Product Profile, QTPP

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

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

Industry Wants FDA to Hit the Brakes on Quality Metrics Program By Michael Mezher - Published 30 March 2017

The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: Quality Metrics

Drug Regulatory Authority of Pakistan: Organizational Structure, Functions and Future Challenges By Shahid Hussain, RPh, PharmD - Published 30 March 2017

This article discusses the development of a more effective pharmaceutical regulatory environment in Pakistan through the establishment of a regulatory agency designed to address current good manufacturing practices and quality management systems for drug production to improve the availability, accessibility and affordability of drugs.

Categories: Features, Compliance, Drugs, Quality, Submission and registration

Tags: DRAP, Drug Regulatory Authority of Pakistan

Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration By Zachary Brennan - Published 28 March 2017

With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion.

Categories: News, Asia, Canada, Europe, US, APEC, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical supply chain, good manufacturing practices, good distribution practices, fake drugs

FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants By Zachary Brennan - Published 21 March 2017

The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma.

Categories: News, US, FDA, TGA, WHO, Compliance, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: breast implants, lymphoma, BIA-ALCL

FDA Offers 2016 Report on Medical Countermeasure Activities By Zachary Brennan - Published 20 March 2017

As part of efforts to protect the US against chemical, biological, radiological, and nuclear (CBRN) threats, the US Food and Drug Administration (FDA) approved seven new treatments and 21 new devices in FY 2016, according to a program update on medical countermeasure (MCM) activities.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Quality

Tags: medical countermeasures, Ebola, Zika, flu vaccine

EC Unveils Revised Guideline on Pharmaceutical Excipients By Zachary Brennan - Published 28 February 2017

The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated. 

Categories: News, US, EC, EMA, Compliance, Drugs, Quality

Tags: excipients, excipient guideline, European Commission guidance

EU Court of Justice Clarifies Product Liability for Notified Bodies By Michael Mezher - Published 20 February 2017

The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives.

Categories: News, Europe, EC, Medical Devices, Quality

Tags: European Court of Justice, TÜV Rheinland, PIP Breast Implants, Notified Bodies

EMA Weighs New Guideline on Quality Requirements for Combination Products By Zachary Brennan - Published 16 February 2017

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: News, Europe, EMA, Combination products, Quality

Tags: combination products, notified bodies, quality requirements

CDRH and CDER Send Warning Letters to Six Asian Companies By Zachary Brennan - Published 14 February 2017

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: warning letters, China drug manufacturing, India drug manufacturing