Biosimilars Guidances
This page lists Biosimilars Guidance documents.
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Safety Labeling Change Orders
Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(o)(4)) authorizes FDA to require application holders for certain drugs to make labeling changes based on new safety information. Learn more. -
Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination
Middlefield, OH 9/5/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6 oz. and 1.25 lb. packages, one lot of Organic Gouda Cheese in 8 oz. packages, and specific lots of Mozzarella/P -
FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perio -
FDA Launches Green List to Protect Americans from Illegal Imported GLP-1 Drug Ingredients
The U.S. Food and Drug Administration today established a “green list” import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market. -
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss -
Designated standards prioritisation
The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.
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Endico Potatoes Inc. Recalls 2.5lb Bags of Frozen “Peas And Carrots” and “Mixed Vegetables” Because of Possible Health Risk
ENDICO POTATOES of MOUNT VERNON NY is recalling Endico brand PEAS AND CARROTS AND MIXED VEGETABLES, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other -
GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) GenoGenix, LLC. Boca Raton, FL. 483 issued 07/18/2025
FEI Number 3032144832
Firm Name GenoGenix, LLC
Record Type 483
State FL
Establishment Type Outsourcing Facility -
Complex Innovative Trial Design Meeting Program
As displayed in the Federal Register notice on August 1, 2018, FDA is conducting a Complex Innovative Designs (CID) Meeting Program to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs, as highlighted in the sixth iteration o -
Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.
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Increased risks identified with Profemur cobalt chrome modular neck hip replacements
Patients implanted with affected devices should expect to be contacted directly for a follow-up assessment, if required.