Guidelines – Page 6 – Policy & Medicine

FDA Issues Guidance on Real-World Evidence for Medical Devices

FDA Releases Guidelines for Physicians Using Investigational Drugs in Emergency Situations

FDA Offers Draft Guidance on E-Submissions of REMS Documents

FDA Issues Draft Guidance on Biologic License Applications

FDA Releases Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

Chicago Releases Draft Rules on Industry Representative Licensure

FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and Biosimilars

FDA Extends Wait for Biosimilar Interchangeability Guidance

FDA Releases Draft Guidance on Manufacturer Communications with Payors, Formulary Committees, and Similar Entities