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BIO Calls on Appropriators to Fully Fund FDA

BIO issued letters today encouraging support for programs and initiatives of critical importance to our …

“No Need to Label GMOs” Says FDA

The Nation’s Leading Regulatory Body on Food Safety Reaffirms Safety of GMOs On March 28, …

FDA: Vaccines a Critical Tool in Protecting and Promoting Public Health

Yesterday, Dr. Karen Midthun of the FDA wrote about the important role of vaccines in promoting public …

U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14

During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, …

4 Tips for Building a Successful Biotech: Richard Pops of Alkermes at #BIOCEO14

The 16th Annual BIO CEO & Investor Conference opened with a fireside chat between Richard …

BIO Responds to GPhA Citizen Petition on Biosimilars Naming

Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting …

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), …