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A Major Automated Information System (MAIS) is an acquisition program for an Automated Information System (AIS) that meets Acquisition Category (ACAT) IA requirements listed below.
A REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration to manage known or potential serious risks associated with a drug product. The ProliaÂ® REMS program materials are designed to inform healthcare providers and patients about these risks with ProliaÂ®. They include a REMS Letter for Healthcare Providers, Patient Counseling Chart for Healthcare Providers, Patient Brochure, Journal Information Piece, Prescribing Information, and Medication Guide.