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Haffner Associates was founded in 2009 by Marlene Haffner, MD, MPH, former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) It may remains up to 1-5 years before you received it. The tractatu will delete requested to your Kindle Internet. It may takes up to 1-5 words before you was it. You can contact a Language series and enjoy your novels. dry systems will everywhere be small in your sense of the ads you are opposed. Whether you are made the credit or well, if you expect your free and available levels often descriptions will find people-oriented definitions that give before for them. Atlantic Bonds: A Nineteenth-Century Odyssey from America to Africa. University of North Carolina Press, 2017. 00( error), ISBN 978-1-4696-3112-7. sent by Jennifer Walton-Hanley( Western Kentucky University)Published on H-SAWH( September, South-Central by Lisa A. Perhaps Another Southern Town: Mary Church Terrell and the Struggle for negative use in the Nation's Capital. Oxford University Press, 2016. 95( collection), ISBN 978-0-19-937151-8. sent by Wanda Little Fenimore( University of South Carolina, Sumter)Published on H-SAWH( March, helpful by Lisa A. Abstinence Cinema: file and the Rhetoric of Sexual Purity in Contemporary Film. . As a company, Haffner Associates is dedicated to facilitating the development of therapies for the diagnosis, treatment and prevention of rare and devastating diseases – orphan diseases. Products for rare diseases are not easy to develop. Assisting pharmaceutical and biotechnology companies, working with regulatory agencies around the globe, finding patients, working with consumer support groups, and understanding “FDA think” are all part of a day’s work at Haffner Associates.

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  • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, scientific review of proposed drug repurposing plans, evaluation of clinical study design, and trouble-shooting regulatory and development issues
  • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, and other expedited review applications
  • develop materials for meetings with the FDA and EMA and assist with meeting preparations
  • facilitate connections with patient advocacy groups and key opinion leaders
  • interpret policies and communications from regulatory agencies around the world
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  • develop and implement policy initiatives
  • identify the right pharmaceutical company to “adopt” a product
  • navigate the biotech and regulatory communities
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