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Policy

A total of 181 posts are filed under Policy
10.17.2018
Policy
FDA Issues Draft Guidance on Pre-IND Meetings for Rare Disease Drug Development
10.12.2018
Policy
Making the Case for an FDA Rare Disease Center of Excellence
10.1.2018
Policy
U.S. Food and Drug Administration Orphan Drug Designations in September 2018
FDA Awards 12 Grants to Fund Clinical Trials to Advance Rare Disease Treatments
9.25.2018 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
Bill Would Seek to Bridge Development Gap for Rare Disease Drugs with Megafund
9.19.2018 Rare Daily Staff A federal bill intended to address what its authors call the “ever-widening funding gap” between basic research and… Continue Reading
Proposal Calls for Creation of FDA Rare Disease Center of Excellence
9.13.2018 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
9.11.2018 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
Patient System to Help Diagnose People in European with Rare Diseases
9.10.2018 Rare Daily Staff A new system developed by Irish health informatics company OpenApp for the European Commission allows secure online… Continue Reading
ACMG Call for National Policy to Control Drug Costs
9.10.2018 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”
9.7.2018 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
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