Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
Chemcial diagram of probable carcinogen N-nitrosodimethylamine linked to FDA's investigation of nitrosamines in drugs that began after an independent testing firm in 2019 submitted petition showing it in OTC heartburn remedies with ranitidine as an active ingredient. • Source: Alamy
