Food and Drug Administration

The 14th Annual BIO CEO & Investor Conference was held on February 13-14 in New York City at the Waldorf=Astoria

Underlying the PDUFA V recommendations are the principles that a science-based, transparent, and well-managed review process that appropriately balances benefits and risks can enhance public trust and increase patient access to new medicines.

Regulatory review processes are not keeping up with rapidly advancing science and are making the environment for developing new treatments and preventions for deadly and debilitating diseases more difficult.

You might have heard that the Prince of Wales, just days after hosting the Royal Wedding, paid us a visit here in Washington.  Prince Charles, a long-time organic food advocate and self-described environmentalist, was here to speak at a Washington Post symposium on the Future of Food.

A new report analyzing FDA-approved monoclonal antibodies (mAbs) produced by a select group of leading biotechnology companies shows that clinical development times – specifically the duration of Phase II and Phase III trials – are lengthening, while FDA review times have remained constant.

President’s call for more funding comes as Congress focuses on reducing budget deficits.

Biotech research holds a great deal of promise for future innovation in the treatment of previously untreatable diseases. But how long does it take for a biotech therapy to come to market?