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Regulatory Insights

The path to regulatory approval for your drug or device can be long and challenging. Let our expert advice and perspectives help you to make the journey smoother.

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Drug Development and Regulatory

Preparing for Successful Meetings with the FDA

FDA meetings provide sponsors the opportunity to seek out critical agency feedback, identify gaps in required data, and come to agreement on whether the studies that have been conducted are sufficient for review. Learn the top 4 ways to help ensure your meeting is a success.

Outsourcing Regulatory Affairs

Regulatory affairs can expedite a drug or device’s development – or stop it dead in its tracks. Delays can be costly to developers and patients alike. If you’re planning to outsource your product’s regulatory affairs or regulatory writing, here are four keys to help you choose wisely.

Requesting Fast Track designation

Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

Medical device classification

The way the FDA classifies a medical device can have a significant impact on a sponsor’s regulatory strategy, business and operations. Here, get expert answers to commonly asked questions about medical device classification.