
FDA Drug Information
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Silver Spring
Joined July 2009
FDA releases final guidance on developing drugs for early Lyme disease. Guidance focuses on localized & disseminated disease; covers trial design, safety & efficacy; & aims to support drug development. Learn more: #LymeDisease #FDAGuidance.
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#FDA approves a treatment for adults with resectable locally advanced head and neck squamous cell cancer whose tumors express PD-L1.
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The FDA plays an important role in #clinicaltrials by reviewing protocols, monitoring safety, inspecting sites, evaluating data, & more. The collective effort of participants, researchers, healthcare teams, and regulators helps bring therapies to patients.
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Today, #FDA releases 48 new PSGs to facilitate generic drug development, including treatments for postpartum depression, lung disease and Duchenne muscular dystrophy. This effort aims to improve access to safe, effective, and affordable medications.
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