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Canon Medical Vantage Orian MRI Cleared

[ Price : $8.95]

FDA clears a Canon Medical Systems 510(k) for its new premium MRI system, Vantage Orian 1.5T.

Priority Review for Tecentriq Plus Chemo in Breast Cancer

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FDA accepts for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy for first-line treatme...

PolyPid IND for Phase 3 Surgery Infection Trial

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FDA approves a PolyPid Ltd. IND for it to proceed with a Phase 3 clinical trial involving lead candidate D-Plex[100] for preventin...

Info Collection on Device Fees for Small Businesses

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Federal Register notice: FDA seeks comments on an information collection extension on a guidance for Medical Device User Fee Small...

Global Biotech Development Surge Continues: Tufts Study

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A Tufts Center for the Study of Drug Development analysis says the global biotech product development surge that started in the 19...

Prostate Cancer Trial Endpoint Guidance

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FDA issues a draft guidance on considerations for using a metastasis-free survival endpoint in some prostate cancer drug trials.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include StemGenex Biologic Laboratories and U.S. Vascular.

FDA Accepts Shire sNDA for Pediatric Short Bowel Syndrome

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FDA accepts for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pe...

Info Collection on IND Sponsor Surveys

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Federal Register notice: FDA submits to OMB a new information collection entitled Surveys and Interviews With Investigational New ...

510(k) Substantial Equivalence Guidance Explained

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CDRH biomedical enginer Ifeanyi Uwemedimo explains provisions in a newly-finalized guidance on benefit-risk assessments for 510(k)...