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U.S. PIRG and other advocacy groups urge that stricter enforcement of post-market clinical trials for accelerated approval drugs b...[ Price : $8.95]
FDA publishes a draft guidance with questions and answers on developing antibacterial therapies for patients with an unmet medical...[ Price : $8.95]
Vanda Pharmaceuticals asks the DC federal court to set aside an FDA determination that the companys tradipitant does not qualify f...[ Price : $8.95]
FDA clears a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism.[ Price : $8.95]
FDA places a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF...[ Price : $8.95]
FDA releases the FDA-483 with six observations from an inspection at Indias Aurobindo Pharma drug manufacturing facility.[ Price : $8.95]
Four medical device stakeholders voice general support for an FDA proposal to harmonize the medical device Quality System Regulati...[ Price : $8.95]
CDER researchers describe a study of mouth-throat models for generic metered-dose inhalers to help generic inhaler manufacturers m...