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Filtering on: "topics quality"

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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

ICH Offers Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

Spanish Regulator Suspends Vaccine Company for Quality Violations By Michael Mezher - Published 06 February 2017

The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) has withdrawn Spanish drugmaker Euro Far Alergi's good manufacturing practice (GMP) certificate over quality issues uncovered during a three-day inspection of the company's Madrid, Spain facility in January.

Categories: News, Europe, Biologics and biotechnology, Compliance, Quality

Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations By Michael Mezher - Published 31 January 2017

The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December.

Categories: News, Europe, Latin America and Caribbean, Drugs, Manufacturing, Quality

Tags: AIFA, Italian Medicines Agency, Antibioticos do Brasil, ABL

FDA Warns Five Medical Device, Three Pharma Companies By Zachary Brennan - Published 31 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters for five medical device companies and three pharmaceutical firms located in India, China, Canada, Korea, Germany and Italy – further revealing the depth of the agency’s international work.

Categories: News, Asia, Canada, Europe, US, FDA, Drugs, Medical Devices, Quality

Tags: warning letters

FDA Bans Imports of Piston Syringes From Nipro’s Thailand Site By Zachary Brennan - Published 25 January 2017

The US Food and Drug Administration (FDA) on Tuesday added Nipro’s Thailand site to a list of companies barred from shipping supplies of medical devices to the US because of a lack of quality.

Categories: News, Asia, US, FDA, Crisis management, Medical Devices, Quality

Tags: Nipro, piston syringes, FDA import alert

FDA Warns UK Drugmaker for Repeat GMP Violations By Michael Mezher - Published 25 January 2017

The US Food and Drug Administration (FDA) has warned UK-government owned Porton Biopharma Limited for repeat good manufacturing practice (GMP) violations at its Salisbury, UK facility.

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

Tags: Porton Biopharma, Jazz Pharmaceuticals, Erwinaze

EMA Updates Q&A on Article 31 Referrals By Michael Mezher - Published 24 January 2017

The European Medicines Agency (EMA) on Tuesday issued a new version of its questions and answers (Q&A) guide on Article 31 non-pharmacovigilance referrals.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Quality

Tags: Article 31 referral, Article 31

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

FDA Form 483 Cites 14 Observations for Zimmer Biomet By Zachary Brennan - Published 19 January 2017

Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Warsaw, IN-based site with 14 observations.

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

Tags: Zimmer Biomet, Form 483, CAPA

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

ICH Offers Reflection Paper on Good Clinical Practice Revisions By Zachary Brennan - Published 12 January 2017

The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct.

Categories: News, Asia, Canada, US, ICH, Clinical, Quality, Regulatory intelligence, Regulatory strategy

Tags: Good Clinical Practice, ICH guidance, ICH E6, ICH E8

Mammogram Record Retention: FDA Offers Advice By Zachary Brennan - Published 05 January 2017

Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Categories: News, US, CDRH, Crisis management, Medical Devices, Quality, Regulatory intelligence

Tags: mammogram, FDA and mammography, MQSA

Spanish Regulator Cites Madrid Drugmaker for Manufacturing Violations By Michael Mezher - Published 20 December 2016

The Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a statement of non-compliance to Madrid, Spain-based drugmaker Angulema, S.L., and ordered the recall of more than 400 lots of the company's vaccines.

Categories: News, Europe, Biologics and biotechnology, Manufacturing, Quality

Tags: AEMPS, Angulema

FDA Proposes New Rule on Bulk Substances Used to Compound Drugs By Zachary Brennan - Published 15 December 2016

The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Manufacturing, Quality

Tags: drug compounding, 503A bulks list, bulk drug substances, APIs

Quality and Compliance, Regulatory Research, Policy Issues and a Preview of December By Gloria Hall - Published 02 December 2016

The following is a summary of feature articles posted throughout November with links and a preview of what's to come in December.

Categories: Features, Compliance, Quality

Tags: Regulatory Focus, Feature Articles, Feature Summary

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

The Measure of Quality By Jennifer DiMarco - Published 29 November 2016

This article details how regulatory professionals can measure the quality of the outputs generated from the quality department. Additionally, the terms Quality Assurance (QA), Quality Control (QC) and quality management are often erroneously used interchangeably. Included are details about how these terms differ.

Categories: Features, Quality

Tags: Quality assurance, Quality control, Quality management

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