Extrusion-Based Methods
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Innovations in Oral Drug Delivery: Challenges and Opportunities
Abstract: The advancement of novel drug manufacturing technologies offers immense opportunities for innovation but brings regulatory complexities that must be addressed to ensure successful implementation. Early and frequent collaboration with the FDA is fundamental for overcoming these challenges. The establishment of the FDA’s Emerging Technology Team has been pivotal in fostering open dialogue, brainstorming, and feedback between regulators and innovators, reducing the likelihood of unexpected setbacks that could jeopardize projects. Mechanisms …
Published in Trends in Drug Delivery · Vol. 12, Issue 1, 2025 · pp. 31–43 Read article