Business · 03/03/2009
FDA Releases Draft Guidance on Clinical Pharmacology Section of Labeling for Human Prescription Drugs
The Food and Drug Administration (FDA) has made available a draft guidance document to help pharmaceutical companies comply with new labeling regulations for human prescription medications and biological products, outlining the recommended content and format for the clinical pharmacology section of labeling.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →