Theorem Clinical Research

Ethics/Regulatory

Article: Change common rule to increase minority voices in research

Monday, October 21, 2013 02:08 PM

An article to be published in the American Journal of Public Health recommends changing the federal regulations that govern research oversight to address continued underrepresentation of minorities in research studies.

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Sanofi, Merck participate in pilot for rapid European health technology assessment

Friday, October 18, 2013 11:06 AM

Sanofi Pasteur MSD is the first vaccine company to have successfully participated in a pilot testing a new rapid relative effectiveness assessment of health technologies in Europe.

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FDA staff returns to work

Friday, October 18, 2013 09:02 AM

A message on the FDA website from Health and Human Service secretary Katheleen Sebelius thanked readers for their patience throughout the lapse in Federal funding. She said, “The uncertainty of the past few weeks has created many difficult situations, and the shutdown has imposed hardships on many employees as well as the public we serve.”

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Health advocates react to California Gov.’s rejection of patient access to biosimilars bill

Monday, October 14, 2013 02:19 PM

Supporters of SB 598 are reacting with disappointment over California Gov. Jerry Brown’s veto of legislation that would have made the necessary updates to state regulations in anticipation of FDA approval of biosimilar medicines. SB 598 received overwhelming bipartisan approval throughout the legislative process, passing 176-13 in five committees and three floor votes in the Assembly and Senate.

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PPMD calls for new collaborative approach to benefit/risk analysis with FDA

Wednesday, October 9, 2013 02:07 PM

Parent Project Muscular Dystrophy (PPMD), a patient advocacy organization fighting to end Duchenne muscular dystrophy, has proposed a collaboration with the FDA to initiate a rare disease benefit/risk pilot program using Duchenne as the initial therapeutic area.

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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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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

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

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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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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