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. FDA officials advised the company last July, before initiating the clinical trial that “although these were Medical Foods and no NDA would be applied for, Targeted Medical Pharma should still apply for an IND.”...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections. "This guideline aims to collate and explain the requirements for the TMF as covered in the Regulation [(EU) No 536/2014] and ICH-GCP E6 to assist organisations in ma...

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. Since 2013, EMA says it has received a total of 43 of such reports detailing a variety of issues and allegations, from the manuf...

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018. Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Drafts Guidelines on Controlling Against False Positives in Clinical Trials The European Medicines Agency (EMA) has released draft guidelines about multiplicity in clinical trials. The text deals with how to mitigate the risk of false positives arising when clinical trials look at multiple treatment groups and endpoints. EMA’s guideline is applicable to most clini...

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). Following an inspection at the clinical site between 15 August 2016 and 14 September 2016, FDA says in the letter that Indianapolis-based Cassandra Curtis, MD, failed to adhere to the investigational plan’s protocol requiring certain subjects to be excluded an...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays. According to the agency, more than half of the approximately 1,000 clinical trial applications submitted each year require additional information before they can be reviewed and approved. While MHRA typically reviews clinical trial applications for ...

Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...

Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports. In an article published in JAMA on Monday, Anna Davis and James Miller of Johns Hopkins Bloomberg School of Public Health say that FDA's position as the global leader in drug regulation "may be undermined" if it is not able to match EMA's efforts. "The proactive publication of clinical study rep...

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections. Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as ...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Posts Comprehensive Technical Guidance on Clinical Trials China Food and Drug Administration (CFDA) has released technical guidance on clinical trials, walking drug developers through the entire clinical research process, from preparing to run a first-in-human trial to designing post-marketing and pharmacogenomic studies. CFDA has created the document to provide ...