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Senate and House Leaders Eager to Push Cures Act Through

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Senate and House leaders signal strong interest in seeing the 21st Century Cures Act signed into law this year.

Comments Sought on Radiation Product Requirements

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Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on reporting and recordkeepin...

Draft Guide on Surgical Aspirator Device Labeling

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Federal Register Notice: FDA makes available a draft guidance on Product Labeling for Certain Ultrasonic Surgical Aspirator Device...

Partial Clinical Hold Lifted on Adaptimmune T-cell Therapy

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FDA removes a partial clinical hold on a Adaptimmune Therapeutics planned study of its NY‑ESO SPEAR (Specific Peptide Enhanc...

Multiple Violations at Cantrell Drug Company

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FDA publishes an FDA-483 with 12 inspection observations from Cantrell Drug Co., an outsourcing facility.

FDA Starts Neurological Device Web Site

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FDA launches a new Web site to help sponsors and innovators of neurological medical devices.

FDA OKs Opdivo for Head/Neck Carcinoma

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FDA approves Bristol-Myers Squibbs Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma o...

Group Wants FDA Warning on Dental Amalgam

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Consumers for Dental Choice asks FDA to take three steps to warn dentists, parents, and dental consumers against amalgam use in ch...

21st Century Cures May Be on Fast Track

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Political analysts see the possibility for compromise 21st Century Cures legislation to be approved by the lame duck Congress that...

Inspector General EpiPen Records Sought

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Sen. Chuck Grassley asks the HHS inspector general for records relating its 2009 determination that the EpiPen had been misclassif...