Guidance On NDA OTC Reportable Label Changes Among US FDA's Planned For 2021
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
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Final guidance, for pharmaceutical alcohol used as an active or inactive ingredient in other drugs as well as hand sanitizers, “will help pharmaceutical manufacturers avoid using pharmaceutical alcohol contaminated with or substituted with methanol in drug products.”
Draft guidance will help sponsor-investigators working on individualized gene therapies. The focus on basic administrative and procedural aspects of interaction with the FDA leaves many policy and commercialization questions about how these personalized investigational products should be studied unanswered.
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.