Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

While the FDA maintains the legal right to make prescription meds OTC, legal expert Heidi Gertner believes that this wider shift depends on pharma’s engagement.

Food and Drug Administration (FDA) Commissioner Marty Makary recently stated that when it comes to drugs that currently require a prescription, "everything should be over the counter" (OTC) unless ...

The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway for more to come.

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

One day after the FDA’s new director of the Center for Drug Evaluation and Research (CDER), Richard Pazdur, M.D., informed colleagues of his sudden and unexpected retirement, one of his lieutenants ...

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has grappled with how to handle new vaccine guidance. The agency has changed — five ...

Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has proposed to discontinue the sale of products ...

A PLANNED shift to online filing for over-the-counter (OTC) medicines is expected to ease processing bottlenecks at the Food ...

The US Food and Drug Administration (FDA) has announced new action to encourage companies to develop naloxone products for over-the-counter (OTC) use — or apply to switch certain products from ...