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FDA releases the form FDA-483 with 10 observations from an inspection at Japans Sato Pharmaceutical over-the-counter drug manufact...[ Price : $8.95]
FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra Life...[ Price : $8.95]
FDA grants Opna Bio an orphan drug designation for its investigational treatment OPN-2853 (zavabresib) for treating myelofibrosis.[ Price : $8.95]
A United States Pharmacopoeia study finds that protective purchasing following information on drug shortages can adversely affect ...[ Price : $8.95]
FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices shou...[ Price : $8.95]
FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.[ Price : $8.95]
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufactur...[ Price : $8.95]
Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studie...