Regulatory Strategies for Orphan drug Development in USA–Europe

Objectives of the present work are as follows: • To study the current principles of rare diseases & orphan drugs. • To study the assessment, challenges and regulatory frame work of orphan drugs • To study the integrated approach for the development and approval of orphan drugs. • To carry out th...

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Veröffentlicht in:	Research journal of pharmacy and technology 2021-06, Vol.14 (6), p.3449-3454
Hauptverfasser:	D.M, Ranjini, Basha G, Sadiq, N., Prabakaran
Format:	Artikel
Sprache:	eng
Schlagworte:	Cystic fibrosis Disease Drug development Drugs FDA approval Federal regulation Marketing Medicine Mutation Natural history Ovarian cancer Principles Rare diseases
Online-Zugang:	Volltext
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