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Sequester Threatens FDA Mission

One aspect of sequestration isn’t doing anything to reduce the deficit, but could be delaying …

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

Panelists in this morning’s opening session outlined strategies for the FDA to better engage the …

FDA Consumer Update: Advances in Saving Lives with Blood

Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of …

New FDA Final Guidance on Clinical Trial Institutional Review Boards

On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators …

FDA Issues Final Guidance on Clinical Trial Oversight

The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach …

What OxyContin Tells Us About the Value of “Evergreening" and Patents

A few weeks ago, the  FDA announced that they would not allow generic versions of …

Legislative Hopes, Fears

Biotechnology advances are poised now more than ever to help policymakers achieve their goals of …

Approving Drugs for Alzheimer’s Disease

BIOtechNOW delves into the current state of Alzheimer’s disease research with today’s feature on regulatory …

Orphan Drugs: Making Rare Diseases Rarer

A panel at the BIO CEO & Investor Conference provided an analysis of the thriving …

Simpson Bowles Keynote to Address Debt, Taxes, Government Services and Politics

I was recently asked what the single biggest threat to the biotechnology industry is today.  …