Opinion|Videos|March 20, 2025

Examining the 505(b)(2) Pathway and Implementation into EHR

Name: Examining the 505(b)(2) Pathway and Implementation into EHR
Uploaded: 2025-03-20T13:42:05.006Z
Duration: 46 min 59 s
Description: Examining the 505(b)(2) Pathway and Implementation into EHR

Author(s)Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, Anthony Boyd, PharmD, BCPS

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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Examining the 505(b)(2) Pathway and Implementation into EHR

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