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2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over...
The U.S. Food and Drug Administration (FDA) recently issued the Federal Register notice “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription...
NCPA submitted comments to FDA’s proposed rule, Nonprescription Drug Product With an Additional Condition for Nonprescription Use. According to the proposed rule, under an ACNU, a drug manufacturer must ensure that patients can appropriately self-select a medication.
In support of the American Telemedicine Association's Telehealth Awareness Week (September 18-24, 2022), Jones Day's Digital Health team shared key insights on various legal topics...
NCPA joined APhA, ASCP, NASP and NACDS in signing onto a letter calling for FDA to extend the comment deadline for the Nonprescription Drug Product With an Additional Condition for Nonprescription Use proposed rule by at least 90 days to allow stakeholders to appropriately respond. Since comments are due Oct. 26, the extension, if granted, would allow comments to be submitted until about Jan. 26.