Module 9 2024

03/09/2024

FDA Vaccine Guidance

https://www.fda.gov/vaccines-blood biologics/biologics-guidances/vaccine-and-related biological-product-guidances

The Organisation for Professionals in Regulatory Affairs

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⚫ “General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases” FDA Vaccines Guidances …..what to look for

⚫ “Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product”

⚫ Guidances on post-market safety reporting for vaccines

⚫ Guidances for the evaluation of combination vaccines, viral vaccines, plasmid DNA vaccines

⚫ Plus, specific guidances on Influenza, Therapeutic Cancer, and COVID-19 vaccines

The Organisation for Professionals in Regulatory Affairs

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