Module 9 2021

23/03/2021

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

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FDA Vaccines Guidances …..what to look for

 General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases

 Guidance for Industry: Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product

 Guidance for Industry: For the evaluation of combination vaccines for preventable diseases: production, testing and clinical studies

 Plus other specific guidelines on Influenza, HIV and Therapeutic vaccines

 And also general guidances for biologial products

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