Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the United States.
FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. FDA Council can help modify your drug labeling to comply with FDA regulations. FDA Council provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.
A Drug Master File is a submission to FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. FDA Council’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.
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Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by FDA.