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.

[Read More]

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.

[Read More]

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.

[Read More]

FDA updates blood donor referral policy

Tuesday, December 22, 2015

The FDA has issued final guidance outlining updated blood donor deferral recommendations to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products. [Read More]

Cummings criticizes Turing’s fake price cut

Friday, December 4, 2015

Rep. Elijah Cummings (D-Md.), ranking member of the House Committee on Oversight and Government Reform, has sent a letter to former hedge fund manager Martin Shkreli, CEO of Turing Pharmaceuticals, condemning his company’s efforts to tout a 50% “price cut” for Daraprim after the company increased the price of the drug in August by 5,000%.

[Read More]