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Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured,...more
Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more
Today, the FDA issued four new biosimilar guidances, as well as a proposed rule. According to a statement by FDA Commissioner Scott Gottlieb, two of the guidance documents - the draft guidance titled “The ‘Deemed to be a...more