[HTML][HTML] Exploring the potential challenges for developing generic orphan drugs for rare diseases: A survey of us and european markets
VR Murthannagari, GGN Krishnan, KV Manu… - Value in Health …, 2023 - Elsevier
Abstract Objectives The US Food and Drug Administration in 1983 and the European
Union's European Medicines Agency in 2000 implemented the orphan drug development …
Union's European Medicines Agency in 2000 implemented the orphan drug development …
Anticipating reforms to the prescription drug user fees act
The study by Monge et al1 was written by senior officials at the US Food and Drug
Administration (FDA) and provides a detailed overview of novel drug approvals and the use …
Administration (FDA) and provides a detailed overview of novel drug approvals and the use …
[PDF][PDF] Risk assessment of failures in generic drug development and approval procedure under competitive generic drug therapy and patent challenge exclusivities …
MV Reddy, GNK Ganesh, B Babu… - Acta Marisiensis-Seria …, 2022 - sciendo.com
Objective: The United States Food and Drug Administration implemented two exclusivity
programs Competitive generic therapy and Patent Challenge exclusivity to develop generic …
programs Competitive generic therapy and Patent Challenge exclusivity to develop generic …
Indie Illness: An Evaluation of the Orphan Drug Act
N Castellanos - 2022 - egrove.olemiss.edu
The purpose of this study is to evaluate the Orphan Drug Act of 1983 by subtracting the cost
of incentives for drug development from the estimated value created by each drug in the …
of incentives for drug development from the estimated value created by each drug in the …
Modifying criteria for orphan drug market exclusivity in USA
MP Socal - PharmacoEconomics & Outcomes News, 2020 - Springer
Modifying criteria for orphan drug market exclusivity in the US would affect only a small
number of dugs but could generate large cost savings, according to findings of a study …
number of dugs but could generate large cost savings, according to findings of a study …
Reply to Comment on “Market Exclusivity for Drugs with Multiple Orphan Approvals (1983–2017) and Associated Budget Impact in the US”
We appreciate the interest that Manning and readers have shown in orphan drug policy [1].
The incentives established in the 1983 Orphan Drug Act have undoubtedly become a …
The incentives established in the 1983 Orphan Drug Act have undoubtedly become a …