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Regulatory

A total of 61 posts are filed under Regulatory
U.S. Food and Drug Administration Orphan Drug Designations in September 2018
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FDA Awards 12 Grants to Fund Clinical Trials to Advance Rare Disease Treatments
Rare Daily Staff The U.S. Food and Drug Administration said that it has awarded 12 new clinical trial research grants totaling more than $18… Continue Reading
Proposal Calls for Creation of FDA Rare Disease Center of Excellence
Rare Daily Staff A pair of attorneys specializing in regulatory law have authored a proposal that calls for the creation of an FDA Rare… Continue Reading
Greater Transparency Would Improve Patients’ Understanding of FDA Actions
When the U.S. Food and Drug Administration declines to approve a new medicine, its delivers the news to the drug developer in what’s known… Continue Reading
ACMG Call for National Policy to Control Drug Costs
ACMG Issues Policy Statement to Address Affordability of Treatments in Rare and Ultra-Rare Disorders Rare Daily Staff The American College… Continue Reading
FDA Action on FCS Drug Sparks Patient Group “Outrage”
Daniel S. Levine A rare disease patient group is calling on the U.S. Food and Drug Administration to reverse itself and “demanding” the… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in August 2018
Source: U.S. Food and Drug Administration Posted September 7, 2018… Continue Reading
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