Roundtable Discussion: Reviewing Regulatory Requirements for Different Ophthalmic Drug Administration Routes
Time: 4:00 pm
day: Conference Day One
Details:
- Establishing guidelines for drug development for a disease indication for which there are currently no treatments in the market
- Leveraging lessons from the different delivery approaches and for streamlined regulatory guidance
- Understanding the guidelines for combination between drug and device and combination products for intravitreal injections
- Considering timing and biological division to demonstrate that both drug and device are safe and efficacious to use with each other?
- The device must meet all its medical device regulations while the drug has to meet its regulatory requirements and they both have to meet regulatory requirements together but there aren’t any clear regulatory guidelines at the moment
