FDA Brief: Week of Feb 8, 2016
- Developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults
- Definition of a clinical phenotype, trial design, efficacy, and safety
- Development programs for the treatment of vasomotor rhinitis, a subtype of NAR
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- Developing drug products for treatment of seasonal allergic rhinitis (SAR) in children and adult
- Trial design, effectiveness, and safety for SAR and perennial allergic rhinitis (PAR)
- Based on assessment of :
- Prior allergic rhinitis clinical trials
- Agency’s current understanding of SAR and PAR mechanisms, pathophysiology
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- Based on current technologies – to assist premarket notification submissions for display devices intended for use in diagnostic radiology
- Class II devices intended for controlled viewing conditions to display and view digital images for primary image interpretation
- Application should include:
- Device description & Indications for Use
- Electrical Safety
- Firmware and Software Documentation
- Physical Laboratory Testing
- Labeling
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- Orthopedic devices using ultrahigh molecular weight polyethylene (UHMWPE) – Conventional, Highly crosslinked, Vit E highly crosslinked, Non-conventional
- Determining appropriate information and testing for 510(k), de novo requests, PMA, HDE and IDE
- Characterization of material (e.g.material description, sterility, biocompatibility, mechanical properties, and chemical properties), Biocompatibility and Shelf life
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