Federal Register notice: FDA makes available a draft guidance on Determining Whether to Submit an ANDA or a 505(b)(2) Application.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FDA posts a draft guidance on Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.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Federal Register notice: FDA makes available a draft guidance on Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.
Commissioner Scott Gottlieb says FDA has been expediting reviews and approvals of different dosage forms and generic versions of products as alternate...