Tag Archives: FDA

National Traceability System Moves into Implementation

5616315608_dd9b7a55dd_b

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 >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , ,

Sequester Threatens FDA Mission

FDA115x76

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 >

Health  |  Leave a comment  |  Email This Post
Tags: , , ,

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

95468934

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 >

Health  |  Leave a comment  |  Email This Post
Tags: , , , , , , ,

FDA Consumer Update: Advances in Saving Lives with Blood

AB23475

Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of all ages who are injured, need surgery or who are suffering from illness. The Food and Drug Administration’s primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products. In this interview, Richard Davey, M.D., director of the Division of Blood Applications, Office of Blood Research and Review at FDA Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , , ,

New FDA Final Guidance on Clinical Trial Institutional Review Boards

clinical-trials

On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More >

Health  |  Leave a comment  |  Email This Post
Tags: , , ,