Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...
The FDA’s existing drug development protocol was not designed for increasingly ... A collaborative drug development approach ...
AN2 Therapeutics said it was planning to meet with the U.S. Food and Drug Administration to discuss a development path for ... End-of-Phase 2 meeting with the FDA in the first half of next year ...
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
The Food and Drug Administration ... in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant," Dr. Patrizia Cavazzoni, director of the FDA's ...
In a long-sought move, the US Food and Drug ... process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.” For now, the order is just a proposal. The ...
Mark Hahn and I discuss the critical vulnerabilities in the U.S. drug supply from Hurricanes Helene and Milton.
The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP) ...