Personalized Medicine Will Lead To Changes In FDA Approval Process For New Medications, Von Eschenbach Says (Medical News Today)
Personalized medicine -- the ability to predict how patients will react to certain medications based on their genetic profiles -- will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St.

Orasure Technologies Files For FDA Approval Of Oraquick Rapid Hepatitis C Test (PharmaceuticalOnline)
OraSure Technologies, Inc. recently announced that it has submitted a pre-market approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for a rapid test for antibodies to the Hepatitis C virus ("HCV") utilizing OraSure Technologies' OraQuick technology platform.