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FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...[ Price : $8.95]
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...[ Price : $8.95]
Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.[ Price : $8.95]
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive...[ Price : $8.95]
CDER and CBER seek input to help advance the agencys model-informed drug development program.[ Price : $8.95]
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...[ Price : $8.95]
FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to i...[ Price : $8.95]
CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...