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Monoclonal Biologics In Acute Myeloid Leukemia (aml) Therapy: Translational Strategies, Policy, regulation and Stakeholder Engagement
Author: Paul Faduola1, Alan Hakim, Juli Mansnérus, Atsuko Imai, Rob O’neil
Publisher: Internet Medical Publishing
11 pages
One time payment: €6.08
Required subscription: Academic
Type of publication: Article
DOI: 10.3823/442
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Description:

 Several countries have therefore produced policies aimed at encouraging pharmaceutical and biotechnological companies to develop innovative drugs that are in serious demand in the society. An example of this policy is the Orphan Drug Act which offers exclusive marketing rights, grant support, tax credits for certain clinical development expenses and other incentives for sponsors to develop drugs for rare diseases .

The objective of this paper is to describe the regulatory frameworks pertinent, though not necessarily specific to monoclonal antibodies Gemtuzumab Ozogamicin (“Gemtuzumab” or “Mylotarg”) and to outlined the key regulatory and compliance aspects for drug development and dissemination.

 

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iMedPub Limited is a publishing house registered in UK, publishing medical books and journals since 2005. As an open service to doctors and biomedical researchers, it is driven by clinicians and researchers for themselves, while serving the interests of the general public. iMedPub disseminates research in a tiered system, beginning with our specialty books and journals and then working upwards. The grand vision of iMedPub is a world where all medical researchers and health professionals have an equal opportunity to seek, share and create knowledge. As we are a low cost academic publisher we offer the lowest article processing charges of all biomedical journals and publish books free of charges for authors.

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