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Examining the 505(b)(2) Pathway and Implementation into EHR
A panelist discusses how the 505(b)(2) regulatory pathway provides a streamlined approval process for modified versions of previously approved drugs, allowing pharmaceutical companies to rely partly on existing safety/efficacy data while still requiring new clinical data, commonly used across various therapeutic areas including reformulations, new dosage forms, and drug combinations.
1:14 505(b)(2) Pathway Introduction
6:33 Role of Pharmacists
11:48 505(b)(2) in Oncology
26:00 Medication Management
32:34 Leveraging EHR
44:24 Unmet Needs
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