The Latest News Coming From the FDA and the Institutional Review Board

Ethics/Regulatory

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FDA issues draft guidance on medical devices, launching pilot program with nine companies

Monday, December 5, 2011 09:15 AM

The FDA has issued two draft guidance documents that focus on early-stage development of medical devices.

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FDA issues draft guidance for artificial pancreas device systems

Friday, December 2, 2011 04:32 PM

The FDA has issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

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European Commission launches framework for research and innovation

Thursday, December 1, 2011 01:12 PM

EFPIA, the voice of the research-based pharmaceutical industry in Europe, welcomes the launch of the European Commission’s new Framework for Research and Innovation: Horizon 2020.

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Industry watchers nervous as PDUFA V deadline looms

Monday, November 21, 2011 08:02 AM

PDUFA IV expires Sept. 30, 2012, and several parties already are nervous about its renewal.

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Report: Clinical trials approved in Russia on course in third quarter

Monday, November 7, 2011 11:26 AM

The number of new studies approved in Russia during the third quarter of 2011 reached last year’s level, with the Ministry of Health and Social Development of the Russian Federation (MoH) approving 132 new clinical trials of all types, including local and bioequivalence studies, according to Synergy Research Group (SynRG), a Russia-based CRO. That’s only two trials below the number approved in the year-ago quarter.

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FDA approves 35 new drugs in fiscal year 2011

Friday, November 4, 2011 10:15 AM

Over the past 12 months, the FDA approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.

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CGD report urges regional approach for safer, faster, cheaper clinical trials

Tuesday, November 1, 2011 12:22 PM

Scores of new medicines and other medical products to treat deadly diseases in poor countries are caught in a regulatory labyrinth that slows approvals, raises costs and sometimes puts patients at risk, according to a new report from the Center for Global Development.

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Proposed Common Rule updates focus on consent, definitions, streamlined IRB review, data protection

Monday, October 31, 2011 08:02 AM

A 20-year-old federal policy for protecting human subjects known as the Common Rule is soon to be updated in ways that could modernize how the industry approaches the ethics, safety and oversight of human research.

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FDA awards $2 million to support CERSI

Thursday, October 27, 2011 01:23 PM

The FDA has reported the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).

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Concerns grow over CMS missing Sunshine Act draft deadline as data collection start date looms

Monday, October 17, 2011 08:02 AM

Industry groups have expressed concern about the Centers for Medicare and Medicaid Services (CMS) missing its deadline for drafting regulations to implement the so-called sunshine law, which requires sponsors to publicly disclose payments to physicians and teaching hospitals. Pharmaceutical and biotechnology companies must begin collecting data to comply with the law in less than 11 weeks.

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