FDA Adds/Revises Draft Product-Specific Guidances for 80 Topical Products

The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or to mucosal membranes.

The guidances offer targeted recommendations, including for the design of bioequivalence studies to support abbreviated new drug applications.

The new draft guidances include abametapir, fluorouracil, halobetasol propionate, nitroglycerin, tazarotene and tirbanibulin. The revised drafts cover a variety of drugs such as antibiotics and nonsteroidal medications.

The agency has invited comments on the documents until Dec. 23.

View the updated guidance list here: bit.ly/3DhSHO0.