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Regulatory

A total of 44 posts are filed under Regulatory
5.31.2018
Regulatory
U.S. Food and Drug Administration Orphan Drug Designations in May 2018
5.23.2018
Regulatory
A Reminder that Gene Therapies Are Not Drugs
5.22.2018
Regulatory
Right-to-Try Legislation Passes House, Heads to Trump for Signature
Patent-to-Launch time for Orphan Drugs 2.3 Years Longer than Other Drugs, Report Finds
5.9.2018   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.
5.3.2018 Rare disease patients in the United Kingdom face unusual barriers to accessing medicines because of the multiple review and reimbursement… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in April 2018
4.30.2018 … Continue Reading
FDA Commissioner Seeks 13 Percent Funding Increase for fiscal 2019
4.19.2018 Rare Daily Staff U.S. Food and Drug Administration Commissioner Scott Gottlieb went before lawmakers earlier this week to make the case for… Continue Reading
Why Patient Groups Shouldn’t Dismiss Report on Pharma Influence
4.16.2018 Earlier this month, Kaiser Health News launched “Pre$cription for Power,” a database that tracks Big Pharma contributions to patient… Continue Reading
U.S. Food and Drug Administration Orphan Drug Designations in March 2018
3.30.2018 … Continue Reading
MHRA Grants FCS Patients in UK Early Access to Akcea’s Volanesorsen
3.22.2018 Rare Daily Staff The U.K.’s Medicines & Healthcare products Regulatory Agency said it would allow patients with the rare genetic lipid… Continue Reading
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