“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.

Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.

Targeting a dual biologic for the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis, Coya Therapeutics has joined forces with abatacept biosimilar developer Dr Reddy’s.

Marketers of copies of national brand OTCs are required under FDA regulations to use the same labeling as the brand, a rule that in effect has limited complaints in California state court alleging Prop 65 violations with nonprescription drug labeling to targeting branded product marketers.