On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and exposure, and evolving information about the potential risks…

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product.  Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does not permit the same active ingredient to be simultaneously marketed in both a prescription drug product and a nonprescription…

On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.”  The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January 2019.  FDA’s rules on human subject protection govern clinical investigations regulated by FDA under sections 505(i) and 520(j) of…

On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, and have been working together to harmonize federal regulatory requirements and guidance in this area. This finalizes draft guidance issued in August 2016, which we summarized here.…