Theorem Clinical Research

Ethics/Regulatory

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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Court shuts down U.S. operations of Titan Medical Enterprises

Monday, February 11, 2013 02:56 PM

A federal judge has ordered Titan Medical Enterprises, a Santa Fe Springs, Calif.-based manufacturer, and its owner, James L. McDaniel, to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act.

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FDA offers new guidance on developing drugs for Alzheimer's

Friday, February 8, 2013 11:47 AM

The FDA has issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable dementia.

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GVB BIO licenses biomarker database to FDA

Thursday, February 7, 2013 08:00 AM

GVK Biosciences, a discovery, research and development organization providing a broad spectrum of services, is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial to the FDA in its Biomarker Qualification Process.

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Almac’s new U.S. commercial packaging operations pass FDA inspection

Wednesday, February 6, 2013 09:16 AM

Global service provider Almac has passed FDA inspection of its new U.S. commercial packaging operations located in Audubon, Penn. The inspection took place on Jan. 9 and 10, 2013, from which the regulatory body concluded that the site is fully compliant with Good Manufacturing Practices, with no 483 issued.

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