Ethics/Regulatory

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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Reed introduces bill to strengthen cancer research reporting requirements

Friday, May 4, 2012 03:23 PM

Congressman Tom Reed has introduced legislation in the U.S. House of Representatives which strengthens the enforcement mechanisms of the requirement to publicly report results of cancer trials and research conducted with federal grant money. The goal of the legislation is greater sharing of cancer research results in the search for a cure to cancer.

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French government replaces health products agency, gives additional powers

Wednesday, May 2, 2012 11:06 AM

The French government has replaced the French Food Safety Agency of Health Products with the new National Security Agency of Medicines and Health Products (MSNA).

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Cetero reaches final resolution with FDA

Tuesday, April 24, 2012 03:10 PM

Cary, N.C.-based CRO Cetero Research has reached a final resolution with the FDA over studies the company conducted in its Houston bioanalytical laboratory between April 1, 2005 and June 15, 2010. Following months of open collaboration between Cetero and the agency, the FDA summarized its final decision:

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FDA strengthens international collaboration to ensure quality, safety of imported products

Monday, April 23, 2012 10:53 AM

FDA commissioner Margaret A. Hamburg has released the agency’s “Global Engagement Report,” detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.

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Report: FDA strengthens monitoring of post-approval drug safety

Monday, April 23, 2012 10:19 AM

A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the FDA’s oversight of drugs once they reach the American public, according to a new report by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to post-market drug safety monitoring as to premarket drug review.

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FDA to pilot end-stage kidney disease technology

Monday, April 9, 2012 12:58 PM

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

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Burrill wraps up life sciences industry for Q1 2012

Wednesday, April 4, 2012 03:00 PM

Burrill & Company, a diversified global financial services firm focused on the life sciences industry, has identified more than $2.6 billion in expected funding through nine translational research and early-stage initiatives announced since the end of February.

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