In The Orphan Drug Approval Race, Winner Takes All? Ramifications Of Catalyst Pharms. V. Becerra - Food, Drugs, Healthcare, Life Sciences
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for.
Takeaways For Pharmaceutical Companies Orphan Drug Act Catalyst Pharms Approve Amifampridine Myasthenic Syndrome Administrative Procedure
Source: mondaq.com