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HRT Prioritizes Access To Affordable Naloxone As US FDA Approves Second OTC Formulation

Executive Summary

Co-founder and CEO Michael Hufford says HRT hopes to distribute first commercial supply in early 2024. Firm is engaging additional funding partners to help make its affordable opioid overdose treatment more accessible.

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Califf Hires New US FDA Senior Advisor, But Duties Seem Vague

As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

Califf Hires New US FDA Senior Advisor, But Duties Seem Vague

As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.

Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

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