Theorem Clinical Research

Ethics/Regulatory

FDA postpones Advisory Committee meeting due to government shutdown

Wednesday, October 9, 2013 02:06 PM

ALK, a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment, has announced that due to the U.S. government shutdown, the FDA has temporarily postponed the Allergenic Products Advisory Committee meeting scheduled for Nov. 6 to discuss the Biologic License Application (BLA) for the investigational grass allergy immunotherapy (AIT) tablet. The FDA has not yet confirmed a new date for the Advisory Committee meeting.

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Scottish drug approval process to become more transparent

Wednesday, October 9, 2013 11:50 AM

Scottish patients will benefit from an increased range of new medicines due to changes announced by Alex Neil, the Scottish health secretary.

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Stakeholders endorse Drug Quality and Security Act

Monday, October 7, 2013 01:18 PM

A broad range of stakeholders has endorsed the Drug Quality and Security Act, legislation introduced by Senate and House health policy leaders to address high-risk drug compounding practices and secure the pharmaceutical supply chain. The bill would improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

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FDA's report on chronic fatigue syndrome reveals impact, progress needed

Friday, October 4, 2013 01:23 PM

Pandora Org, a national nonprofit ME/CFS advocacy organization, and other patient organizations say a recent report from the FDA shows it must take further action to open up opportunities for ME/CFS drug development. Titled The Voice of the Patient, this report is a detailed summary of an April 25 FDA patient-focused drug development meeting, the first of its kind, at which patients explained the reality of Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS).

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Government shutdown already affecting clinical trials industry

Friday, October 4, 2013 08:58 AM

Last week, when the government shutdown began, stories of children with cancer unable to get into potentially life-saving trials at the National Institutes of Health (NIH) were the first clinical research-related ramifications reported.

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URAC launches revised Case Management Accreditation program

Wednesday, September 11, 2013 01:48 PM

URAC has launched its enhanced Case Management Accreditation Standards and Measures, with an optional Transitions of Care Designation. URAC’s Case Management Accreditation program allows for the application of case management standards across all care settings, helping organizations demonstrate outcomes-based, patient-centered, high-value quality care.

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EFPIA responds to EMA draft policy on access to clinical trial data

Wednesday, September 11, 2013 01:20 PM

EFPIA, representing the research-based pharmaceutical industry in Europe with a membership of 33 national associations and 40 pharmaceutical companies, has concerns about the EMA draft policy (0070) on publication and access to clinical trial data, saying it carries negative implications for public health in its failure to adequately protect the interests of patients and the research from which they benefit.

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EMA now accepting Safe-BioPharma digital signatures on eSubmissions

Friday, September 6, 2013 02:53 PM

Beginning this month, SAFE-BioPharma digital signatures will be accepted by the European Medicines Agency (EMA).  

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John Hopkins study suggests neurologists unaware of drug risks

Friday, August 16, 2013 10:41 AM

A study by Johns Hopkins researchers shows a fifth of U.S. neurologists appear unaware of serious drug safety risks associated with various anti-epilepsy drugs, potentially jeopardizing the health of patients who could be just as effectively treated with safer alternative medications.

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Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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September 22

Roche/Genentech plans pilot trial to measure patientpreference for participating at home v. at study site

Bipartisan 21st Century Cures initiative prepares to draft legislation to accelerate biomedical R&D, lower cost

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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