As the demand for COVID-19 diagnostic tests soar, the FDA guidelines around emergency-use authorization continue to shift. Discover what has changed and what that means to your FDA approval path in this 30-minute webinar.
- FDA priorities
- Paths to commercialization
- Modifications for use in laboratories and POC
- Post-authorization conditions
- Links to resources
- 5 key takeaways
About the speaker:
Experienced Regulatory Affairs professional with a demonstrated history of working in the biotechnology industry. Career has been focused on Medical Devices and IVDs. Strong regulatory professional with over 20 years of experience.
Jo-Ann F. Gonzales, RAC
Director IVD Regulatory & Quality Consulting
View the talk below.