FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.
CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.
Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...
FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...
Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).
Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis.
FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.
FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthalmic solutions.
