Ethics/Regulatory

FDA seeks $5.1B for FY 2017

Wednesday, February 10, 2016

The FDA is requesting a total budget of $5.1 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2017 budget—an 8% increase over the enacted budget for FY 2016. The overall request includes a net increase of $14.6 million in budget authority and $268.7 million in user fees for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act (FMSA) and efforts to improve medical product safety and quality. The agency is also seeking $75 million in new mandatory funding to support the National Cancer Moonshot initiative being led by the vice president.

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Bipartisan legislation introduced to combat Zika virus

Friday, February 5, 2016

U.S. Representatives G. K. Butterfield (NC-01) and Susan Brooks (IN-05) have introduced H.R. 4400, a bipartisan bill that seeks to add the Zika virus to the list of diseases included in the Tropical Disease Priority Review Voucher Program at the FDA. The Zika virus, which is transmitted to humans by mosquitoes, can infect pregnant women and result in birth defects, including microcephaly and neurological disorders in newborns. The virus also causes skin rashes, conjunctivitis, muscle and joint pain, and headaches in adults. The World Health Organization has labeled Zika a global public health emergency.

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MasterControl now offers UL training courses

Tuesday, February 2, 2016

UL EduNeering courses, a global gold standard for Quality & Compliance eLearning programs, are now available directly from MasterControl, a global provider of electronic quality management systems (EQMS) and quality consulting services. The SCORM-compliant Quality & Compliance Essentials courses, available via the MasterControl Training module, are sets of self-paced eLearning courses that are targeted to specific areas of a life science compliance program. These course sets allow teams to focus on key proprietary topics rather than on developing and conducting in-house training programs.

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FDA gives guidance to sponsor-investigators

Friday, January 15, 2016

Last May FDA released a draft guidance designed to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).1 “Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process,” the draft guidance says. This guidance is not an exhaustive step-by-step instruction manual but rather a document that “highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND.” The guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.

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