Guidelines – Page 3 – Policy & Medicine

FDA Releases Draft Guidance on Benefit-Risk Principles

FDA Finalizes Guidance to Help Regulated Industries with Voluntary Recalls

FDA Publishes Guidance on Premarket Pathways for Combination Products

FDA Issues New Set of Guidances Focused on Generic Drug Submissions and Labeling Updates

FDA Issues Two Draft Guidance Documents on Real-World Data

Interim Final Rule with Request for Comments Released, Requiring More Transparency

FDA Revises COVID-19 ANDA Guidance

AdvaMed Releases Code of Ethics on Interactions with Health Care Professionals in India

FDA Updates Final Guidance on Biosimilar Development

FDA Finalizes Guidance on Field Alert Report Submissions