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Rydkina, S

FDA explains that a bulk drug substance used through the 503A pathway generally must meet one of the following conditions: Comply with an applicable United States Pharmacopeia or National Formulary monograph Be a component of a drug product with federal marketing authorization when no applicable monograph exists Appear on the 503A Bulks List when the first two pathways do not apply Additional requirements also apply, including documentation and sourcing requirements for the bulk drug substance

Game changer

In a vote of regulatory confidence, the FDA granted fast-track regulatory designation to tau antibodies from Bristol Myers Squibb (BMS-986446) and Eisai (etalanetug) late last year