Draft Guidance for Industry on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This draft guidance is one of a series of guidance documents intended to assist applicants in complying with new FDA regulations on the content and format of labeling for human prescription drug and biological products. The draft guidance describes the recommended information to include in the Clinical pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products.