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Tagged: 505(b)(2)

BBCR’s team of experts help clients match treatments to rare genetic conditions and unsolved diseases, then work cohesively with a product developer on the best plan to market.

May 4th, 2022 | 505(b)(2)

Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs? Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can […]

Drug Repurposing can lower the need for early stage clinical trials. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases.

December 9th, 2021 | 505(b)(2)

According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug reformulation. In addition, the development of drug repurposing compared to a […]

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