Orphan Drug and Generic Approvals Both on Track for a Record Breaking 2017

According to Rare Disease Report, “It is only August but the U.S. Food and Drug Administration (FDA) is on track to set a record for orphan drugs approved this year. At last count, 42 orphan drugs have been approved between January 1, 2017 and August 9, 2017.”  Meanwhile, RAPS Regulatory Focus reports that “A little more than 10 months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year.”

Here’s the orphan story, the generic story, and a link to contact us if you need help with either.