Labeling for Prescription Drugs, Biologics and Combination Products – Webinar Recording/ Transcript
Labeling for Prescription Drugs, Biologics and Combination Products: Complying with FDA’s Most Recent IFU Guidance
The FDA guidance on Instructions for Use (IFU) issued in July 2019 aims to make labeling of prescription drugs, biologics and combination products clearer and more helpful to patients. But this could have implications for your business’ NDAs and BLAs.
If you’re unsure how to proceed, you’re not alone. In this presentation, Alan G. Minsk, Esq. — a partner and leader of the Food & Drug Practice Team of Arnall Golden Gregory LLP — will clarify the new guidance and explain how to comply with it, focusing on the issues you must consider as you implement changes to your IFUs.
- Why FDA issued the draft guidance and its importance to regulatory, quality and compliance specialists, including the content and format concerns of FDA in general and details necessary for safe and effective use
- What kind of language IFUs should be written in to be patient friendly
- What the guidance recommends in terms of voice, commands and sentences
- Examples of sample labeling that covers all elements of an IFU from dosage and usage to storage and disposal
- What kinds of recommendations FDA makes in terms of design and layout, such as the use of easy-to-read fonts, sequential numbering and white space
- Some practical considerations on patient labeling, from a business perspective
If you are at all unclear how to implement this guidance and change your IFUs to include what FDA considers to be “clear, concise information that is easily understood,” you listen to this presentation. Your NDAs and BLAs depend on it.