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TXT Attorneys Weigh FDA Reporting of Cybersecurity Upgrades [1748 Words] [ Price : $8.95]
A client alert by DLA Piper attorneys reviews when a cybersecurity-related change to a device is reportable to FDA.
TXT FDA Allows Marketing of Becton Dickinson Vaginitis Assay [1169 Words] [ Price : $8.95]
FDA approves a de novo petition to allow marketing of a Becton Dickinson molecular test to detect the most common causes of vaginitis.
TXT FDA Clears Onkos Limb Salvage System [1121 Words] [ Price : $8.95]
FDA clears an Onkos Surgical 510(k) for the Eleos Limb Salvage System to treat patients with significant bone loss due to cancer, trauma, or previous surgical procedures.
TXT FDA, Catalyst Agree on Trial Protocol for LEMS Therapy [1175 Words] [ Price : $8.95]
FDA and Catalyst Pharmaceuticals reach an agreement under a special protocol assessment for the protocol design, clinical endpoints, and statistical analysis approach in an upcoming Phase 3 study evaluating Firdapse (amifampridine phosphate) for the symptomatic treatment of Lambert-Eaton myasthenic syndrome.
TXT Lawmakers Face Tug-of-war Over 21st Century Cures Bills [1423 Words] [ Price : $8.95]
Medical research groups call on the House and Senate leadership to pass the 21st Century Cures Act when they return to work in November, while some liberal groups urge its delay while changes are considered to reign in drug costs.
TXT Washington Legal Foundation Examines Off-label Promotion [1515 Words] [ Price : $8.95]
A Washington Legal Foundation legal backgrounder examines the recent convictions of two Acclarent (Johnson & Johnson subsidiary) executives in U.S. v. Facteau (see story) and the questionable boundaries that currently separate speech from criminal conduct.
TXT Comments Sought on BLA Reporting Requirements Extension [1107 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to BLA general licensing provisions.
TXT Comments Sought on Device Educational Program Surveys Extension [1120 Words] [ Price : $8.95]
Federal Register Notice: FDA seeks comments on a submission to OMB seeking to extend an information collection related to “Testing Communications on Medical Devices and Radiation-Emitting Products.”
TXT FDA OKs St. Jude Stroke Reducing Device [1341 Words] [ Price : $8.95]
FDA approves a St. Jude Medical PMA for the Amplatzer PFO Occluder device to reduce the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart.
TXT FDA Guidance on Essure-type Device Labeling and Warnings [1192 Words] [ Price : $8.95]
FDA releases a guidance on “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” that addresses the necessary warnings and risk information to inform healthcare providers and patients before such procedures are performed.
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