FDA MOVES TO SPEED NEW DRUG APPROVALS

Pharmacy Times, Volume 0,0

The FDA announced steps to acceleratethe earliest phases of clinical research forimportant new medicines to treat suchlife-threatening conditions as cancer, heartdisease, and neurologic disorders.

The new approach will help more researchersconduct earlier, more informedstudies of promising treatments so thatpatients have more rapid access to saferand more effective drugs.

Officials at the Pharmaceutical Researchand Manufacturers of America(PhRMA) praised the FDA for taking actionthat may significantly reduce the timerequired to bring new-generation drugs tothe market. PhRMA President and ChiefExecutive Officer Billy Tauzin hailed theFDA's action as a move that will "improveand accelerate the research and developmentof new medicines that can helppatients suffering from potentially deadlydiseases live longer, healthier lives."

According to Tauzin, "too many timespromising new treatments fall through thecracks because the process involved?canbe arduous and full of red tape." Speedingthe clinical review process will "encouragerapid delivery of innovative treatments forpatients who don't have time on theirside," he said.