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Filtering on: "topics compliance"

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EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO By Zachary Brennan - Published 24 March 2017

The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.

Categories: News, Europe, EC, EMA, Compliance, Generic drugs, Product withdrawl and retirement, Research and development

Tags: Indian CRO, CRO suspension, EMA suspension, generic drugs

FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

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

Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice By Zachary Brennan - Published 14 March 2017

When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice.

Categories: News, Europe, MHRA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Ethics

Tags: Celgene, Takeda, Pierre Fabre, PMCPA, ABPI

New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India By Zachary Brennan - Published 14 March 2017

The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Government affairs

Tags: warning letters, API manufacturers, water and pharmaceuticals

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

Categories: News, US, CDRH, Compliance, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Class II devices, 21st Century Cures, FD&C Act

EU Industry Groups Urge Caution on Biosimilar Switching By Zachary Brennan - Published 09 March 2017

Three EU biopharmaceutical industry groups are offering key considerations to physicians when switching from a biologic reference product to its biosimilar or from one biosimilar of a reference product to another, according to a new position paper released on Thursday.

Categories: Europe, EC, EMA, Biologics and biotechnology, Compliance, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, biosimilar switching, regulatory requirements biosimilars

FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance By Michael Mezher - Published 08 March 2017

The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues.

Categories: News, US, FDA, Compliance, Drugs, Manufacturing

Tags: Warning Letter, Data Integrity

FDA Warns China API Manufacturer for Data Integrity Violations By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues.

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

Tags: Data Integrity

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

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars By Zachary Brennan - Published 15 February 2017

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Labeling, Regulatory intelligence, Regulatory strategy

Tags: biosimilars, nonproprietary names for biosimilars, nonproprietary names for biologics, FDA guidance

FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials By Michael Mezher - Published 15 February 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.

Categories: News, US, CBER, Advertising and Promotion, Blood, Compliance, Drugs

Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

May Deadline for FDA's eCTD Transition Approaches By Zachary Brousseau - Published 13 February 2017

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to FDA all New Drug Applications, Biologics License Application and Abbreviated New Drug Applications using the electronic Common Technical Document (eCTD).

Categories: HTML, Articles, Under RAPS, RAPS, Compliance, Generic drugs, Prescription drugs, Submission and registration

Tags: eCTD, electronic Common Technical Document, Submissions

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

CDRH Warns Three Foreign Medical Device Manufacturers By Zachary Brennan - Published 07 February 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

Categories: News, US, CDRH, Compliance, Manufacturing, Medical Devices

Tags: warning letters, quality data

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

GOP Sets June Deadline for Completing FDA User Fee Reauthorizations By Zachary Brennan - Published 06 February 2017

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Medical Devices, Research and development

Tags: FDA user fees, PDUFA, MDUFA, BsUFA, GDUFA, user fee reauthorization

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February By Gloria Hall - Published 06 February 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February.

Categories: Features, China, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, Biologics and biotechnology, Compliance, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles, Feature Summary

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance By Zachary Brennan - Published 06 February 2017

The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward.

Categories: Compliance, Crisis management, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: "two out, one in," Trump regulatory policy, FDA regulations

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

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