Pilot 1 Fails to Fly
This article was originally published in RPM Report
FDA is unlikely to make permanent its rolling review, fast-track Pilot 1 program. The agency says logistics are the key reason for the program's termination.
You may also be interested in...
Accelerated Approval Does Not Speed Oncologics To Market, Study Finds
Development time is the same for cancer drugs cleared under subpart H and under the regular approval pathway, according to a study in the Journal of Clinical Oncology. Article calls attention to idea that cancer drugs may need new, more favorable FDA policies on surrogate markers.
Designer Labeling: Drug Safety Reform Proposals Include New Powers for FDA
The time has come when the pharmaceutical industry will have to answer for Vioxx. Congress will address drug safety in 2007. That means FDA could get new authority over the heart and soul of any new drug-the label.
Time to Pay the Piper? Industry Prepares for a Fight Over User Fees
The pharmaceutical industry and FDA are getting ready for a fight-and for once they are on the same side. They want Congress to reauthorize the Prescription Drug User Fee Act quickly and cleanly-without tacking on other reforms to FDA's drug regulations. They probably won't get their wish.