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Regulatory

A total of 64 posts are filed under Regulatory
12.4.2018
Regulatory
GAO Finds FDA Granted Orphan Drug Designation to Some Applications Missing Required Information
12.3.2018
Regulatory
U.S. Food and Drug Administration Orphan Drug Designations in November 2018
10.24.2018
Regulatory
U.S. Food and Drug Administration Orphan Drug Designations in October 2018
Why Rare Disease Drug Developers Need Regular Interaction with the FDA
10.19.2018 Despite accelerated pathways for the development and approval of rare disease therapies, significant challenges remain for companies wishing… Continue Reading
FDA Issues Draft Guidance on Pre-IND Meetings for Rare Disease Drug Development
10.17.2018 Rare Daily Staff The U.S. Food and Drug Administration issued a draft guidance addressing the role of meetings with the agency prior to… Continue Reading
Making the Case for an FDA Rare Disease Center of Excellence
10.12.2018 Two attorneys specializing in regulatory law recently proposed the creation of an FDA Rare Disease Center of Excellence to better allow the… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in September 2018
10.1.2018 … Continue Reading
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
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
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