As we begin the new year, there is a lot of talk in the drug development world about Federal Drug Administration (FDA) guidance documents for clinical and decentralized clinical trials (DCTs). This chatter is understandable because we’re likely to see some emphasis put into previous documents that have not been rigidly enforced.
Unfortunately, a lot of trial sponsors aren’t thinking about these guidance documents in a holistic manner; rather, they are treating them in silos. And that’s a mistake
Catalyst Pharmaceuticals Comments on FDA's Announcement of its Position on Orphan Drug Exclusivity In Light of the 11th Circuit Decision in Catalyst Pharmaceuticals, Inc. v. Becerra
Announced Earlier Today-Notice Received from ANDA Filer for FIRDAPSE®
CORAL GABLES, Fla., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (NASDAQ: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients l