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Policy

A total of 168 posts are filed under Policy
FDA Issues Set of Gene Therapy Draft Guidances
Rare Daily Staff The U.S. Food and Drug Administration today issued six draft guidance documents, part of an ongoing effort to provide a… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in June 2018
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Not Just a Pipe Dream
The U.S. Food and Drug Administration this week approved GW Pharma’s Epidiolex to treat seizures associated with Lennox-Gastaut syndrome… Continue Reading
CMS Says Drugs Approved through FDA Accelerated Approval Must Be Covered
Rare Daily Staff The Centers for Medicare and Medicaid Services issued a notice to state Medicaid programs saying that drugs approved under… Continue Reading
DOJ Says It Won’t Defend ACA in Latest Challenge to Constitutionality—Threatens Protections on Pre-Existing Conditions
Rare Daily Staff The U.S. Department of Justice said it agrees with plaintiffs in a lawsuit that seeks to throw out as unconstitutional the… Continue Reading
Alliance for Regenerative Medicine Launches Foundation to Promote Understanding of Cell and Gene Therapies
Rare Daily Staff The Alliance for Regenerative Medicine has launched the ARM Foundation for Cell and Gene Medicine to educate and engage the… Continue Reading
Genome Canada Creates Rare Disease Pilot to Serve as Foundation for Precision Health Initiative
Rare Daily Staff Genome Canada has launched a national initiative for the clinical implementation of precision health with a pilot program… Continue Reading
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