Start / PharmaTalkRadio / Enhanced strategic fda collaboration working with cder and cber

PharmaTalkRadio

Enhanced Strategic FDA Collaboration: Working with CDER and CBER

30 min • 26 juni 2025

This podcast features a panel discussion from the 2025 Chief Medical Officer Summit 360° with biotech CMOs across indications about how CMOs can best support their regulatory teams and engage with the FDA and other regulators. Specifically, the panelists address:

Engaging with the FDA on a peer-to-peer level
Effectively negotiating about innovative approaches that may be outside of guidelines
How to react and respond to feedback and questions from the FDA

To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

Senaste avsnitt

Directors' Talk DPHARM 2025 - AI Sessions; Part III

25 juli | 6 min

Innovations in Manufacturing to Make CAR-T More Accessible and Affordable

25 juli | 20 min

Achieving Oral Delivery of Peptides through Formulation and Molecule Design Approaches

25 juli | 29 min

Catalyzing Change: The Business Imperative of Patient-Centric Drug Development

21 juli | 26 min

How Emerging Biopharma CMOs Can Better Partner with Patient Organizations

21 juli | 32 min

Podcastbild

00:00 -00:00

Podcastbild

00:00 -00:00