January 23, 2019
FDA Places Clinical Hold on Translate Bio’s Application to Begin Trials for mRNA…
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January 17, 2019
FDA Updates Rare Disease Guidance for Drug Developers
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January 16, 2019
FDA Announces New Initiatives to Advance Cell and Gene Therapies
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December 31, 2018
U.S. Food and Drug Administration Orphan Drug Designations in December 2018
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December 4, 2018
GAO Finds FDA Granted Orphan Drug Designation to Some Applications Missing Required Information
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December 3, 2018
U.S. Food and Drug Administration Orphan Drug Designations in November 2018
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October 24, 2018
U.S. Food and Drug Administration Orphan Drug Designations in October 2018
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October 19, 2018
Why Rare Disease Drug Developers Need Regular Interaction with the FDA
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October 17, 2018
FDA Issues Draft Guidance on Pre-IND Meetings for Rare Disease Drug Development
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October 12, 2018
Making the Case for an FDA Rare Disease Center of Excellence
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