In its latest bid to address health care costs, the Food and Drug Administration issued a new guidance that offers suggestions for drug makers seeking to switch their prescription medicines to a so-called non-prescription status.
The guidance, which the agency called a “first step,” is designed to encourage drug makers to think about ways to seek approval for over-the-counter approvals. A new FDA regulation that would formalize such an approach is expected next year, but the agency emphasized that approval standards for over-the-counter medicines are not being lowered.
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