CDER Small Business and Industry Assistance (SBIA) Regulatory Education for Industry (REdI) Conference "Prescription Drug Labeling - Challenges and Issues Presentation Slides

                                    

Agenda

• CDER SBIA Regulatory Education for Industry (REdI) Conference: Prescription Drug Labeling - Challenges and Issues - Agenda

Day 1

• CDER SBIA Regulatory Education for Industry (REdI) Conference: Prescription Drug Labeling - Challenges and Issues - Agenda
• Challenges and Issues With Safety-Related Information in the Prescribing Information (Trentacosti)
• Challenges of Drug Interaction Information in Labeling - Strategies for Enhancing Quality, Utility, and Clarity in Drug Interaction Labeling: A Regulatory Perspective (Retzinger)
• Patient Medication Information (Ebel)

Day 2

• PLLR: Implementation and Challenges
• PLLR
• Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors for Drug Products
• Common Deficiencies in Container Label and Carton Labeling for Biological Products
• Drug Labeling and Its Impact on Promotion
• Beginning with the End in Mind - The Connection Between Product Labeling and Promotion