Theorem Clinical Research

Ethics/Regulatory

FDA takes two actions on drug shortages

Friday, November 1, 2013 11:14 AM

The FDA is taking two actions to further enhance its ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order to reduce drug shortages, the number of new shortages in 2012 fell to 117, down from 251 in 2011. 

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NHS fears changing data protection rules could erode quality of research in U.K.

Friday, October 25, 2013 11:48 AM

The NHS European office and the Royal College of Physicians have warned a new Europe-wide law on data protection could have a negative impact on healthcare provision and erode the quality and effectiveness of health research in the U.K.

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FDA awards 15 grants to stimulate drug, device development for rare diseases

Wednesday, October 23, 2013 02:36 PM

The FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

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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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