Ethics/Regulatory

Parliament committee adopts amendments to proposed clinical trial regulation

Monday, June 3, 2013 11:35 AM

The European Parliament’s Committee on Environment and Public Health has unanimously adopted reporter Glenis Willmott’s amendments to the Commission’s proposed regulation on clinical trials, including provisions requiring sponsors to publish full clinical study reports once a marketing authorization decision has been taken.

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FDA lifts clinical hold on anthrax vaccine program

Thursday, May 30, 2013 03:24 PM

PharmAthene, a biodefense company developing medical countermeasures against biological and chemical threats, said the FDA has lifted the clinical hold previously placed on a proposed phase II study of SparVax, a next generation recombinant anthrax vaccine.

"Anthrax has been identified as one of the foremost potential biological threats to the nation,” said Eric I. Richman, president and CEO.  “The U.S. government's requirement for a recombinant anthrax vaccine for the civilian Strategic National Stockpile is an important national security imperative that remains unfilled. Next-generation anthrax vaccines like SparVax, which employ modern vaccine technology, offer the potential for improved convenience, cost-effectiveness, more rapid immunity, and the ability for large scale rapid delivery.”

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Bio-Optronics, Schulman Associates IRB to simplify clinical trial management

Friday, May 3, 2013 11:30 AM

Bio-Optronics, a software and services provider, and Schulman Associates IRB, an international, AAHRPP-accredited independent IRB, announced their partnership and their newly integrated regulatory compliance module for the Clinical Conductor Enterprise CTMS application. This collaboration offers Clinical Conductor Enterprise CTMS users streamlined IRB interactions from one centralized location.

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EMA publishes initial list of medicines under additional monitoring

Friday, April 26, 2013 10:22 AM

The European Medicines Agency has published the initial list of medicines that are subject to additional monitoring, representing an important deliverable of the new European pharmacovigilance legislation.

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AUA co-sponsoring public FDA workshops

Wednesday, April 24, 2013 11:58 AM

The American Urological Association (AUA) will co-host two FDA public workshops to address research in the areas of bladder and prostate cancer. The events, free and open to the public, will take place in San Diego on May 5 and May 6, during the AUA's annual scientific meeting.

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MHRA prioritizes science and research support as part of new corporate plan

Wednesday, April 24, 2013 10:17 AM

The Medicines and Healthcare Products Regulatory Agency (MHRA) announced its aim to be a leading regulator on the world stage in supporting science and research as part of its new five-year corporate plan.

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Man jailed in pre-clinical trial data scam case

Wednesday, April 24, 2013 09:49 AM

A man has been sentenced to three months in prison for altering pre-clinical trial data designed to support applications to perform clinical trials.

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FDA to hold meeting on “serious disease” chronic fatigue syndrome

Monday, April 22, 2013 11:19 AM

The FDA will hold a first-ever public workshop on April 25-26, 2013, to discuss how best to facilitate and expedite the development of safe, effective drug therapies to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The workshop is open to pharmaceutical companies, researchers, clinicians and patients, and it will be live-streamed online.

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FDA requests $4.7B budget to ensure safety of food supply, modernize medical product safety

Friday, April 12, 2013 11:41 AM

The FDA is requesting a budget of $4.7 billion to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94% of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

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ABPI to introduce new clinical trial transparency measures

Friday, March 1, 2013 02:42 PM

The Association of the British Pharmaceutical Industry (ABPI) will put in place measures to monitor compliance to the clinical trial transparency provisions contained in the ABPI Code of Practice. An independent, third-party service provider will be appointed to undertake this work, and the ABPI will take on the responsibility for reporting non-compliance with trial registration and posting of summary results.

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