FDA Grants Approval to CeloNova Biosciences’ COBRA PzF Stent System March 1, 2017 The stent improves coronary luminal diameter in patients. Read More
Cell Medica Granted FDA Fast Track Designation for Lymphoma Immunotherapy March 1, 2017 The product previously received Orphan Drug designations from the FDA. Read More
FDA Awards Philips’ ElastQ Imaging Assay Marketing Clearance February 28, 2017 ElastQ Imaging enables simultaneous imaging of tissue and assessment of liver stiffness. Read More
Drugmakers Ask for Choice Between Product and Site Quality Metric Reports February 28, 2017 An FDA official offered an update on the agency’s reissued draft guidance for quality metrics. Read More
FDA Awards Voxello Marketing Clearance for Speech Generation Device February 27, 2017 The device enables patients to control up to three different devices with a single touch. Read More
FDA Requests Comments on Pediatric Postmarketing Pharmacovigilance and Drug Use Reviews February 27, 2017 The docket for comments will be open for 2 weeks. Read More
FDA Clears Expanded Indication for Vidas Brahms PCT Assay for Lower Respiratory Tract Infections February 24, 2017 The test is for use in hospitals or emergency rooms. Read More
FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials February 24, 2017 The draft guidance covers the implementation of a single section of the Q11 manufacturing guideline. Read More
India Finalizes New Regulations Specifically for Devices February 23, 2017 All medical devices sold in India will require a unique device identification by 2022. Read More
CTTI Publishes Recommendations for Pediatric Clinical Trials of Antibiotics February 23, 2017 Sponsors should begin planning pediatrics trials in consultation with the FDA. Read More
FDA Cites Neo Vision for Design Controls February 22, 2017 The company failed to implement design controls and establish a design history file. Read More
GAO Downgrades Rating of FDA’s Action Plans for Postmarket Drug Monitoring and Shortages February 22, 2017 The office called on the agency to routinely analyze the data it collects. Read More