State Importation Program Enhancements

FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal under section 804 of the Federal Food, Drug and Cosmetic Act.Reducing the burden on states: Cost savings analysisFDA intends to work with other divisions...

Guidance for Industry

Docket Number: FDA-2022-D-2301 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Small Volume Parenteral Drug Products...

FLUCELVAX

STN: 125408Proper Name: Influenza VaccineTradename: FLUCELVAXManufacturer: Seqirus, Inc.Indication:For indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.FLUCELVAX is...