The FDA announced steps to accelerate the earliest phases of clinical research for important new medicines to treat such life-threatening conditions as cancer, heart disease, and neurologic disorders.
The new approach will help more researchers conduct earlier, more informed studies of promising treatments so that patients have more rapid access to safer and more effective drugs.
Officials at the Pharmaceutical Research and Manufacturers of America (PhRMA) praised the FDA for taking action that may significantly reduce the time required to bring new-generation drugs to the market. PhRMA President and Chief Executive Officer Billy Tauzin hailed the FDA's action as a move that will "improve and accelerate the research and development of new medicines that can help patients suffering from potentially deadly diseases live longer, healthier lives."
According to Tauzin, "too many times promising new treatments fall through the cracks because the process involved?can be arduous and full of red tape." Speeding the clinical review process will "encourage rapid delivery of innovative treatments for patients who don't have time on their side," he said.
Women with abnormal vaginal microbiota showed no difference in efficacy of daily oral PrEP compared to women with normal vaginal microbiota.
Clinical features with downloadable PDFs