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USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information

Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for Biologics Evaluation and Research, and Office of Regulatory Affairs released a draft and final guidance on “Post-Warning Letter Meetings Under GDUFA” and "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs" respectively.

A Warning Letter is a formal communication from the FDA to a drug manufacturer or distributor when significant violations of regulatory standards are identified during inspections or through other means. It outlines the specific violations and requests prompt corrective actions.

A Post-Warning Letter Meeting, is a meeting with the FDA regarding the facility’s remediation of deficiencies identified in a warning letter.

Generic Drug User Fee Amendments): GDUFA is a law that authorizes the FDA to collect fees from generic drug manufacturers to support the timely review of generic drug applications and ensure the quality and safety of generic drugs.

In this guidance, information is provided on the implementation of the Post-Warning Letter Meeting process, a program enhancement approved by the Agency, and how eligible facilities can request a Post-Warning Letter Meeting with FDA regarding ongoing efforts to correct cGMP deficiencies described in a warning letter, how to submit a complete meeting request package, and how FDA intends to conduct the meeting.

Drug Supply Chain Security Act (DSCSA): Enacted in 2013, the DSCSA aims to enhance the security and traceability of the pharmaceutical supply chain. It outlines a series of requirements and standards to be met by pharmaceutical manufacturers, repackagers, wholesalers, and dispensers.

"Interoperable Information Exchange" refers to the ability of various stakeholders within the pharmaceutical supply chain to share and access critical drug-related information in a standardized and compatible manner. This exchange of information is designed to enhance the traceability, security, and authenticity of certain human, finished, prescription drugs as they move through the supply chain.

To facilitate secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, this guidance identifies standards and clarifies the trading partners, products, and transactions that must comply.


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