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for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Small Volume Parenteral Drug Products...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...

“Peter Michael, M.D. – 711299

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-06-01 Product: Drugs Recipient: Recipient Name Peter Michael, M.D. “Peter Michael, M.D. 1401 East 4th Avenue, Suite 201Hialeah, FL 33010-3504United States Issuing Office: Center for...

Staska Pharmaceuticals, Inc. – 699291

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Lyndon R. Leitner Staska Pharmaceuticals, Inc. 742 Evergreen DriveBennet, NE 68317-2365United States Issuing Office: Center for Drug Evaluation...