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PMA Accepted for TherOx Myocardial Infarction Device

[ Price : $8.95]

FDA accepts for review a TherOx Inc. PMA for its Supersaturated Oxygen Therapy system, intended for use in reducing infarct size a...

FDA Accepts Eisai sNDA for Liver Cancer Therapy

[ Price : $8.95]

FDA accepts for review an Eisai supplemental NDA for Lenvima (lenvatinib) for (XXX DELETE XXX)use in first-line treatment of patie...

FDA/OHRP Guidance on IRB Meeting Minutes

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FDA and the HHS Office for Human Research Protections issue a guidance on Minutes of Institutional Review Board (IRB) Meetings.

FDA Publishes List of 2016-17 PMA Approvals

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Federal Register notice: FDA publishes a list of premarket approval applications that have been approved from 7/1/2016 through 6/3...

Safety Alert Updates Risks with SynCardia Heart Device

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FDA updates a 2016 safety alert to transplant surgeons and cardiologists about additional data that continue to indicate that ther...

FDA, Ophthalmic Groups Hold Workshop on Digital Health

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FDA and several ophthalmic-related medical associations announce a 10/23 workshop entitled Ophthalmic Digital Health to discuss fa...

Guide on Drug Expedited Programs

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FDA makes available a guidance on Expedited Programs for Serious Conditions Drugs and Biologics.

FDA Deploying Staff to Puerto Rico to Help Manufacturers, Residents

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FDA deploys additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically nec...

FDA/SOCRA Clinical Trial Requirements Conference

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Federal Register notice: FDA announces an educational conference co-sponsored with the Society of Clinical Research Associates on ...

Comments Sought on Form 3674 Certifications

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Federal Register notice: FDA seeks comments on a information collection extension for its Certification To Accompany Drug, Biologi...