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Working groups representing both the generic and brand-name pharmaceutical industries told the FDA they need more guidance on how generic versions of abuse-deterrent opioid medications will be reviewed and approved. Read More
With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements and is considering developing more frequent and granular updates to those standards in the future. Read More
With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements, and is considering developing more frequent and granular updates to those standards in the future. Read More