2004 Clinical Pharmacology Regulations 
Drug Target Review
JULY 4, 2023
1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Translational and Clinical Pharmacology [Internet]. Clinical Pharmacology & Therapeutics. Antibody drug conjugated with cytotoxic payload.
Agency IQ
FEBRUARY 12, 2024
Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.
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