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2013 Novel Drug Approvals

The FDA approved 24 novel drugs last year by our count, in line with average …

Congress Passes Omnibus Spending Agreement

This week, BIO President and CEO Jim Greenwood praised the Congress for passing the fundingbill …

FDA Check-Up: Drug Development and Manufacturing Challenges

I have over 27 years of experience in the biotechnology and pharmaceutical industry. My current …

National Traceability System Moves into Implementation

Last week, President Obama signed into law the Drug Quality and Security Act (H.R. 3204), …

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 …