• Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products
• Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) …
• Notice: Release of Draft Guidance Document for Consultation: Comparative Pharmacokinetic Studies for …
• Final Notice: Classification of Dental Plaque-Disclosing Products as Drugs
• Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications