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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.
Video content above is prompted by the following:
- Can you discuss the background and rationale of the 505(b)(2) pathway and in which fields of medicine it is used in?
- As a pharmacist, in what ways are you working with the 505(b)(2) pathway in your everyday practice?
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