Draft Guidance Issued on Optimizing Dosages for Oncologic Disease Treatments; Comments Due March 19

Draft Guidance Issued on Optimizing Dosages for Oncologic Disease Treatments; Comments Due March 19

The Food and Drug Administration (FDA) issued draft guidance on optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases. The guidance is intended to assist sponsors in identifying the optimal dosage during clinical development prior to submitting an application for approval for a new indication and usage. The FDA notes that dosage optimization… (Slifer, January 18, 2023) #Food and Drug Administration, #Prescription Drugs