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FDA posts a final guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.[ Price : $8.95]
FDA approves an Alnylam Pharmaceuticals NDA for Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria Type 1 (PH1), ...[ Price : $8.95]
FDA issues a guidance to assist ANDA applicants for complex products to schedule and conduct several types of meetings with agency...[ Price : $8.95]
CDRH holds a second listening session on its new Digital Health Center of Excellence and examines whether it is pursuing the most ...[ Price : $8.95]
FDA extends from 24 to 36 months the expiration date for 42 lots of Cutaquig if they are stored at a cooler temperature.[ Price : $8.95]
FDA clears a Neuronetics 510(k) for its TouchStar treatment, a three-minute intermittent theta burst protocol for use with its Neu...[ Price : $8.95]
FDA recognizes the ANSI board as an accreditation body for the agencys Accreditation Scheme for Conformity Assessment pilot projec...[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one medical product company AuroLife Pharma.