A federal court orders California dietary supplement manufacturer Custompax Inc. (Freemont, CA) to stop selling its products until the company comes i...
Federal Register notice: FDA makes available a draft guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application.
FDA clears a Royal Philips 510(k) to market the new eL18-4 transducer with full solution for small parts assessment, which is an ultrasound exam to de...
FDA posts a draft guidance on Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.
Federal Register notice: FDA announces a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting that will...
FDA clears a TransEnterix Surgical 510(k) for the Senhance System, a new robotically-assisted surgical device (RASD) for use in minimally invasive sur...
FDA accepts a Prometic BLA for Ryplazim (plasminogen), indicated for treating plasminogen deficiency.
Federal Register notice: FDA makes available a draft guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.