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Drugs for Rare and Infectious Diseases
FDA Drug Approvals for Rare Diseases and Infectious Diseases Generating Antibiotics Incentives Now Act GAIN Act (S.1734)
The GAIN Act provides incentives to help bring new antibiotics and other antimicrobials to market.
A drug with particular promise can be designated as a Qualified Infectious Disease Product (QIDP) by authority of the GAIN Act.
In 2014, FDA/CDER approved four new antibiotics…
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