Header graphic for print
Focus on Regulation

Tag Archives: FDA OTC Drug Review

FDA proposes new ways for prescription drugs to become available over-the-counter

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a prescription, drugs that are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  The draft guidance would facilitate these prescription (Rx) to Over-The-Counter (OTC) switches by allowing

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