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505(b)(2) Services

Published 13 February 2015 | By inVentiv Health

Extending the life of a therapeutic can substantially enhance its value. The 505(b)(2) approval route was designed to encourage innovation, extend the life of a product, and provide an opportunity for market exclusivity, while minimizing the time and cost required for traditional clinical studies. For some products, the reference drugs can be relied upon for the safety and efficacy information (non-clinical and clinical), with some additional work required to establish comparability.

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505(b)(2) Services