Tag Archives: FDA

Congress Passes Omnibus Spending Agreement

Jim Greenwood

This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill for fiscal 2014, which would, among other things, allow the Food and Drug Administration (FDA) to access $85 million in user fees sequestered in 2013. In addition, BIO supports the agreement’s overall funding for: FDA, NIH, the biodefense enterprise; and improved program oversight of the important 340B program.  BIO also strongly supports the language in the bill providing the Department Read More >

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FDA Check-Up: Drug Development and Manufacturing Challenges

Paul Hastings

I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current company, OncoMed Pharmaceuticals, is working at the cutting edge of oncology research, focused on antibodies that target a specific set of cells within tumors, known as tumor initiating cells, that drive the growth of the tumor and can differentiate into various cell types within the tumor. Currently, we have five products in clinical development in over 13 completed or ongoing Read More >

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National Traceability System Moves into Implementation

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Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), which created a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. Inside Health Policy’s Alaina Busch highlighted implementation plans in this November 20 story, “Drug Security Bill Ushers In Compounder Market Shift, 10-Year Effort To Implement Rx Tracing,” which can be accessed here with a subscription. Below are details on implementation based on Read More >

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Sequester Threatens FDA Mission

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One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying patient access to new drugs and medical devices, according to the FDA’s Janet Woodcock at a House subcommittee hearing on Friday. The FDA is being denied access to some of the user fees paid by the drug and device industries, which are intended to fund FDA’s review and oversight programs and ensure timely patient access to new and effective treatments. Read More >

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BIO Patient and Health Advocacy Summit: Patient-Focused Drug Development

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Panelists in this morning’s opening session outlined strategies for the FDA to better engage the patient community to guide the drug development process. “Patients should be providing input and guidance throughout the entire drug review process,” said Marc Boutin, Executive VP and COO of the National Health Council. Boutin highlighted the improvements made through PDUFA V to open up and enhance the Agency’s interaction and engagement with patients. “Integrating our perspective into how drugs are Read More >

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