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Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson,...

Maynard Nexsen on

This week, Heather and Matthew welcome Dr. Fridriksson, a Neuroscientist, Professor, and the Vice President of Research at the University of South Carolina. Dr. Fridiksson is a veteran scientist and has spent much of his...more

Jones Day

FDA Issues Revised Off-Label Communications Guidance

Jones Day on

The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more

Foley & Lardner LLP

Collaborative Review of Scientific Evidence Announced By FDA

Foley & Lardner LLP on

Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an...more

Hogan Lovells

Genetic tests and medication response: FDA announces collaborative review of scientific evidence

Hogan Lovells on

FDA announced the introduction of a collaboration between the Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER) to provide the agency’s view of the current science in...more

Hogan Lovells

FDA guidance may ease path to biosimilar interchangeability

Hogan Lovells on

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable...more

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