Federal Register notice: FDA seeks comments on an information collection extension for Certification of Identity; Form FDA 3975.
Federal Register notice: FDA sends to OMB an information collection for Medical Devices; Shortages Data Collection System.
The U.S. Justice Department announces that a Florida foundation has agreed to pay $4 million to resolve allegations that it violated the False Claims ...
CBER Office of Compliance and Biologics Quality issues RichSource Stem Cells an untitled letter over promotional statements on its Web site for cell t...
Federal Register notice: FDA seeks comments on an information collection extension for General Licensing Provisions; Section 351(k) Biosimilar Applica...
FDA accepts for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks.
President Trump signs a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20.
FDA approves a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults.