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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.
Analysts are predicting a worldwide increase in the biosimilar market over the next 10 years. Here, we share answers to some of the most common questions about this new class of medications.
Breakthrough Therapy designation is one of four FDA expedited programs that seek help ensure that therapies for serious conditions are approved and available to patients as soon as possible. If you’re interested in pursuing a Breakthrough Therapy designation, here are the basics you’ll need to know.
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.
A well-planned IND application can serve as the foundation for a smooth and efficient approval process, while a poorly composed IND can result in costly delays. Learn the key steps to help ensure your IND application gets your product off on the right foot.
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.
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.