29 Mart 2014
Journal for Clinical Studies'de Türkiye'den yazı..
Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries
Rare diseases (RDs) are an important public-health issue and a challenge for the medical community. They are called ?health orphans?, because RDs have been neglected for many years, mainly due to the research and development (R&D) challenges. In the 1960s, amendments were made to existing federal laws in the US, mandating that all drugs must be shown to be safe and effective through ?adequate and well-controlled studies? before receiving market approval development resulted in drugs for small disease populations being ?orphaned? by many major drug companies. Modern society still has a lack of options for the effective treatment of patients with RDs. As one of the consequences of this, the demand for public health protection has increased the economic burden of patients suffering from RDs.
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