On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are currently available only by prescription. The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing
Tag Archives: FDA OTC Drugs
Major FDA Announcement on OTCs
After years of rumbling, the U.S. Food and Drug Administration (FDA) has taken initial steps to examine whether and how to modernize the over-the-counter (OTC) drug review processes and regulatory framework. FDA is exploring ways to re-engineer the OTC monograph system to, among other things, create a process that is more efficient and more responsive