Drug Master Files (DMFs)
Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs:Allow parties to reference material...Quality Metrics for Drug Manufacturing
What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data may lead to higher levels of safety, efficacy, delivery, and performance. ...What is a Botanical Drug?
A botanical drug product is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans. A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations...Inspection/Enforcement Resources
ResourcesInspections Classifications DatabaseThis database provides final inspection classifications for inspections related to currently marketed FDA-regulated products, including inspections of facilities that manufacture, process, pack, or hold an FDA-regulated...CDER’s Advanced Drug Manufacturing Facility
The Center for Drug Evaluation and Research’s (CDER) Advanced Manufacturing Research Facility (AMRF) is a new laboratory for evaluating innovative drug manufacturing technologies and ensuring drugs produced with these technologies are safe, effective, and high...All Drug Purchases Are
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