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Final treatment decisions are made by licensed clinicians based on individual medical history, clinical evaluation, and professional judgment

treatment may impact areas of autism severity, verbal communication, expressive communication, personal daily living skills, coping skills, or socialization, for example

It has gone after some companies for selling research chemicals after determining that the drugs were, in fact, being sold for human consumption, but the agency is playing a game of whack-a-mole

Years of guidance, which include CDER's 2023 discussion paper on AI in drug manufacturing and the January 2026 Guiding Principles of Good AI Practice in Drug Development (developed with the European Medicines Agency), have already set the agency's expectations for manufacturers