FDA commissioner Scott Gottlieb posts a special note of gratitude to thousands of FDAers missing their normal paychecks as the partial government shut...
FDA principal associate commissioner for legislative affairs John Martin announces his departure to lead the government affairs unit at CRISPR Therape...
The U.S. Ninth Circuit Court of Appeals affirms a district court decision siding with dietary supplement maker NBTY over structure/function claims on ...
FDA clears an RFPi Inc. 510(k) for its iCertainty open surgery blood flow and perfusion imaging medical device.
Bloomberg reports that an unidentified California man with glioblastoma is the first patient to receive an experimental therapy under the so-called Ri...
A new study on drug development costs finds that clinical costs per approved orphan drug were half that of a non-orphan drugs.
FDA commissioner Scott Gottlieb says that during the current government shutdown, the agency is continuing to conduct device post-market surveillance.
Sens. Grassley and Klobuchar reintroduce legislation to end so-called pay for delay agreements in which innovator drug companies pay potential generic...