Theorem Clinical Research

Ethics/Regulatory

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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EMA: Small, medium enterprises see consistent improvement in drug approvals

Friday, March 1, 2013 02:39 PM

Micro, small and medium-sized enterprises (SMEs) registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorization applications (MAAs) over the past seven years, according to the SME offices’s 2012 annual report.

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OECD urges countries to harmonize clinical trial regulations to boost research, save lives

Tuesday, February 26, 2013 10:33 AM

Increasingly complex and inconsistent clinical trial regulations are causing delays, raising costs and leading to a decline in the number of international trials conducted by academics for non-commerical purposes. In the E.U. alone, the number of applications for clinical trials fell by 25% between 2007 and 2011.

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Sanford Heisler files $100m+ class action complaint against Daiichi Sankyo

Wednesday, February 13, 2013 10:32 AM

Six current and former female pharmaceutical sales professionals have filed a $100 million class and collective action gender discrimination lawsuit against Daiichi Sankyo, the U.S. branch of the Japan-based pharmaceutical company, in the U.S. District Court for the Northern District of California.

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