Bonnie Odom and Megan Robertson, Members of the Firm in the Health Care & Life Sciences practice, co-authored an article in World Pharmaceutical Frontiers, titled “Solving the EDDO Guidance Puzzle.”

Following is an excerpt:

A long-awaited draft guidance was released by the FDA in June 2024 that establishes and defines new terminology and seeks to clarify expectations from the agency related to Essential Drug Delivery Output (EDDO) requirements. Abi Millar talks to lawyers Bonnie Odom and Megan Robertson, from Epstein Becker Green, about what the EDDO draft guidance entails and how industry has been responding.

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