FDA clears a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio.
FDA denies a petition asking it to standardize hearing aid features in new over-the-counter hearing aids and rate them.
FDA joins the National Institutes of Health in launching a Critical Path for Rare Neurodegenerative Diseases public-private partnership.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys migraine drug Reyvow (lasmiditan).
CDER director Patrizia Cavazzoni removes Bob Temples deputy Center director title and renames him senior advisor for clinical science within the Offic...
CDER issues a Manual of Policies and Procedures for instances in which a CDER special government employee wants to represent a sponsor before FDA.
Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes due t...
FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its biosimilar BLA for a c...
