Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement
Pharmacy Times
JUNE 23, 2025
The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.
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