FDA accepts for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation disorders.
FDA clears an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory devices designed to sup...
A public interest group says FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that led to the recall of...
FDA clears a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air.
FDA Review posts the Federal Register notices for the week ending 10/11/2019.
FDA Review posts product approval summaries for the week ending 6/17/2016.
Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center intends to publish in...
Federal Register notice: FDA submits to OMB an information collection extension for 510(k) Third-Party Review Program.