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The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan. Read More
Closing what it calls an “unintended loophole,” the FDA will no longer issue orphan drug designations for smaller pediatric subpopulations of more common diseases, unless certain criteria are met. Read More
The International Generic Drug Regulators Programme released guidance for quality assessors in regulatory agencies on the preparation of quality assessment reports, and noted the guidance may be useful for anyone responsible for the preparation of quality information submitted to regulatory agencies. Read More