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Regulatory

A total of 49 posts are filed under Regulatory
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
U.S. Food and Drug Administration Orphan Drug Designations in May 2018
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A Reminder that Gene Therapies Are Not Drugs
  FDA Commissioner Scott Gottlieb this week sparked excitement that the agency is readying to release a new framework to help speed the… Continue Reading
Right-to-Try Legislation Passes House, Heads to Trump for Signature
Rare Daily Staff The U. S. House of Representatives passed legislation that would make it easier for terminally ill patients to get access… Continue Reading
Patent-to-Launch time for Orphan Drugs 2.3 Years Longer than Other Drugs, Report Finds
  Rare Daily Staff It takes 15.1 years on average to advance an orphan drug from the first patent filing to product launch—18 percent… Continue Reading
Anarchy in the U.K.
Rare disease patients in the United Kingdom face unusual barriers to accessing medicines because of the multiple review and reimbursement… Continue Reading
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