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Market exclusivity in orphan medicines in USA

Published by FDA

Orphan IncentivePaediatric IncentiveMarket Exclusivity

This guide provides an incentive of FDA. Orphan products once they receive a marketing authorisation in USA, they benifit additional 7 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for rare diseases to prevent from other competitors selling similar drugs for similar diseases.

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Rewards and incentives for paediatric medicines in USA

Published by FDA

Paediatric IncentiveMarket ExclusivityReward

This guide provides an incentive of FDA. Drugs for peadiatric once they receive a marketing authorisation in USA, they benifit additional 6 months of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for children to prevent from other competitors selling similar drugs for similar diseases.

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Rare Diseases: Natural History Studies for Drug Development Guidance for Industry

Published by FDA

Rare DiseaseNatural History

This guidance is intended to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products
for rare diseases. Although the focus of this guidance is rare diseases; the recommendations in the guidance may be applicable to drug development for nonrare diseases.

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