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FDA publishes a draft guidance on the formal dispute resolution and administrative hearing process for over-the-counter monograph ...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of the Medical Imaging Drugs Advisory Committee for an additional two years bey...[ Price : $8.95]
Arrow International recalls its Arrow Endurance Extended Dwell Peripheral Catheter System due to the potential for catheter separa...[ Price : $8.95]
A Bloomberg newsletter covering India reports that Indian drug firms are sharing FDA inspection reports and their responses in an ...[ Price : $8.95]
FDA grants Sarepta Therapeutics an accelerated approval for its BLA for Elevidys, the first gene therapy for treating pediatric pa...[ Price : $8.95]
A 10/2022 inspection of drug outsourcing facility PQ Pharmacy of Brooksville, FL leads to a just-posted seven-item Form FDA-483 th...[ Price : $8.95]
FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.[ Price : $8.95]
FDA approves Sebelas Suflave colonoscopy prep that reportedly tastes like a sports drink and thus is easier to use.