Ethics/Regulatory

Markey, House democrats introduce bill to protect human subjects in clinical trials

Monday, August 6, 2012 11:59 AM

Rep. Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, has introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012 to close clinical trial loopholes and bring certainty and transparency to life-saving research studies.

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EFPIA supports E.C. adoption of clinical trials regulation

Monday, July 23, 2012 01:01 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a group of 33 European national pharmaceutical industry associations and 35 companies, welcomes the proposal for a new regulation on clinical trials on medicinal products for human use adopted July 23 by the European Commission as a first step towards further cooperation in the clinical trials assessment process across the E.U.

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FDA introduces new safety measures for opioid medications

Monday, July 9, 2012 04:36 PM

The FDA has approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

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FDA proposes unique device identification system for medical devices

Thursday, July 5, 2012 12:11 PM

In response to requirements in legislation that passed Congress with broad bipartisan support, the FDA has proposed that most medical devices distributed in the U.S. carry a unique device identifier, or UDI.

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Schulman Associates IRB offers oncology-focused review board

Wednesday, June 27, 2012 03:46 PM

In response to the recent increases in oncology research conducted in North America, Schulman Associates IRB will offer a weekly board meeting of the new Schulman Oncology Board, dedicated to the review of oncology research, beginning July 23.

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EMA boosts transparency with online publication of suspected side effects

Friday, June 1, 2012 11:28 AM

The European Medicines Agency has begun publishing suspected side effect reports for medicines authorized in the European Economic Area (EEA) on a new public website: www.adrreports.eu.

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FDA-led research discovers autoimmune mechanism for drug-induced AEs

Tuesday, May 22, 2012 02:15 PM

A team of researchers led by the FDA has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.

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Amgen provides testimony to FDA stakeholder hearing on biosimilars

Monday, May 14, 2012 01:40 PM

Joseph P. Miletich, M.D., Ph.D., senior vice president of R&D at Amgen, submitted testimony to the FDA stakeholder hearing on biosimilars, urging members of the FDA panel charged with implementing a pathway for biosimilars to establish approval standards that advance patient safety and promote confidence in biosimilars marketed in the U.S.

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BRANY, Veritas IRB to provide AAHRPP-accredited services in U.S. and Canada

Friday, May 11, 2012 12:38 PM

BRANY (Biomedical Research Alliance of New York) and Montreal-based Veritas IRB have partnered to provide clinical trial review, compliance and other IRB services in both the United States and Canada.

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FDA issues alert on potential dangers of unproven treatment for MS

Friday, May 11, 2012 11:54 AM

The FDA is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

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