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Filtering on: "topics compliance"

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EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations By Zachary Brennan - Published 23 May 2017

The European Medicines Agency (EMA) on Tuesday opened for public consultation a new guideline on serious breaches of clinical trial regulations or clinical trial protocols.

Categories: News, Europe, EMA, Clinical, Compliance, Government affairs, Research and development

Tags: clinical trial regulations, EMA guideline

FDA Launches New ORA Structure to Align Inspections With Expertise By Michael Mezher - Published 15 May 2017

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Program Alignment, Office of Regulatory Affairs, Inspections

EMA Report on 2016: 27 New Drugs, New Priority Scheme, Trial Transparency By Zachary Brennan - Published 10 May 2017

With the European Medicines Agency’s (EMA) departure from London and loss of UK expertise (about 60 of the 897 EMA staffers are from the UK) looking more likely, the agency on Wednesday released a report outlining its successes from 2016, when 27 new medicines were authorized and several new programs took shape.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: PRIME, Brexit, EMA in 2016

FDA Warns Indian Firm for Impeding Inspection By Michael Mezher - Published 09 May 2017

The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

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

Tags: Inspection, Warning Letter

Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

FDA Warns Lonza’s Class II Device Manufacturing Site By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

Categories: News, US, CDRH, Biologics and biotechnology, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Lonza, medical device manufacturing, FDA warning letter

Significant Safety Events Found in a Third of FDA-Approved Drugs, Study Finds By Zachary Brennan - Published 09 May 2017

Among 222 novel therapeutics approved by the US Food and Drug Administration (FDA) from 2001 through 2010, 32% were affected by a postmarket safety event, according to a study published in JAMA on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: adverse events, significant safety events, postmarket studies

EMA to Continue to Allow Patient Involvement in CHMP Meetings By Zachary Brennan - Published 08 May 2017

The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before EMA’s Committee for Medicinal Products for Human Use (CHMP).

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs

Tags: patient perspective, CHMP, benefits and risks of medicines

FDA Official Highlights Foreign Supply Chain Challenges By Michael Mezher - Published 05 May 2017

Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research.

Categories: News, US, FDA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Office of Manufacturing Quality, Foreign Inspections, Supply Chain

EMA to Pharma Companies: Prepare for UK to EU Shift By Zachary Brennan - Published 02 May 2017

Setting the stage for a likely exodus from the UK for pharmaceutical manufacturers and staff, the European Medicines Agency (EMA) on Tuesday notified marketing authorization holders (MAHs) that for centrally authorized products, EU law requires them to be established in the EU or European Economic Area, which includes Iceland, Liechtenstein and Norway.

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

Tags: Brexit, pharmaceutical companies in UK, MAHs in UK

New FDA Warning Letter, Form 483 for Two Indian Companies By Michael Mezher - Published 02 May 2017

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Compliance, Manufacturing

Tags: Warning Letter, Form 483

US Supreme Court to Consider Biosimilar Patent Process Next Week By Zachary Brennan - Published 20 April 2017

The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Ethics, Government affairs

Tags: biosimilars, Amgen, Sandoz, patents

Theranos Agrees to Two Year Ban, Refunds Every Arizonan Who Purchased a Blood Test By Zachary Brennan - Published 18 April 2017

As part of an agreement reached with Arizona attorney general Mark Brnovich, the medical device startup Theranos on Tuesday agreed to pay $4.65 million for about 1.5 million blood tests sold to more than 175,000 Arizonans.

Categories: News, US, Compliance, Crisis management, In vitro diagnostics, Medical Devices

Tags: Theranos, blood test, Arizona, CMS

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

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

EMA Board Adopts New Policy on Whistleblowing By Zachary Brennan - Published 10 April 2017

With an aim to encourage whistleblowers and others to feel safe coming forward with possible details of improprieties, the European Medicines Agency’s (EMA) Management Board on Monday adopted a new policy detailing how the agency handles such allegations, including those that could have an impact on the evaluation and supervision of medicines.

Categories: News, Europe, EMA, Compliance, Crisis management, Government affairs

Tags: whistleblower, EMA policy, OLAF, clinical trial whistleblowing

A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers By Zachary Brennan - Published 06 April 2017

As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: Form 483, FDA inspection reports, API manufacturing

FDA Warns Pfizer Clinical Investigator Over Chantix Study By Zachary Brennan - Published 05 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).

Categories: News, US, FDA, Clinical, Compliance, Drugs, Due Diligence

Tags: Chantix, Pfizer, clinical trial, warning letter

EU and US Regulations for Chemical Components in Medical Devices By Kenneth Stanvick - Published 31 March 2017

This article discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US. The author reviews legislation, offers compliance advice and warns about the penalties of noncompliance.

Categories: Features, Europe, US, EC, FDA, Compliance, Medical Devices

Tags: Chemical Components, Restricted Substances

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

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

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

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

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

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