The guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements for prescription reference products, biosimilar products, and interchangeable biosimilar products.
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Notable Approvals | Drugs
News about human drug-related approvalsPine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
FEI Number 3010943533
Firm Name Pine Pharmaceuticals LLC
Record Type 483
State NY
Establishment TypeWells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing FacilityAgebox Inc. – 718252 – 12/19/2025
Unapproved New Drug/MisbrandedIntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/25/2025
Short Title (70 char) IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
FEI Number 3014483112
Firm Name IntegraDose Compounding Services LLC
Record Type 483
State MN
EstabliRecommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs
This guidance provides recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.