With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” which...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
8/22/2017
/ Abbreviated New Drug Application (ANDA) ,
Biotechnology ,
Drug Design ,
Drug Pricing ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Medical Devices ,
New Legislation ,
Orphan Drugs ,
PDUFA ,
Pediatrics ,
Prescription Drugs ,
Product Labels ,
Regulatory Oversight ,
Trump Administration ,
User Fees