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2 articles for “early dialogue”
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Horizon Scanning and Early Assessment of Health Technologies for the Treatment of Orphan Diseases
Abstract: The theoretical foundations and regulatory framework of the processes of the formation of an effective health technology assessment (HTA) system at the early stages of the life cycle of medicines are analyzed in the article. Particular attention is paid to horizon scanning (HS) and early assessment of expensive innovative drugs utilized for treating rare diseases. In order to inform policymakers, purchasers, and providers (to prioritize MT research, financial, and operational …
Published in International Journal of Brain Sciences · Vol. 1, Issue 1, 2024 · pp. 32–39 Read article
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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