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Electronic Format Regulatory Submission Guidance

[ Price : $8.95]

FDA publishes the first in a series of guidances with standards for medical device submissions in electronic format.

FDA Slowness Helped e-Cig Epidemic: Rep. Pallone

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House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017...

FDA Gives Danicopan Breakthrough Designation

[ Price : $8.95]

FDA grants breakthrough therapy designation to Achillion Pharmaceuticals danicopan for treating paroxysmal nocturnal hemoglobinuri...

Abiomeds Newest Heart Pump Approved

[ Price : $8.95]

FDA approves Abiomeds newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) a...

FDA Breakthrough Status for Concussion Device

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FDA grants Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating co...

Florida Canadian Drug Importation Plan

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Florida submits a concept paper to HHS explaining how it wants to operate a Canadian prescription drug importation program.

Draft Guide on Patient Input on Device Trials

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Federal Register notice: FDA makes available a draft guidance entitled Patient Engagement in the Design and Conduct of Medical Dev...

Trump Said to Modernize, Improve Flu Vaccines

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The White House says President Trump has signed an executive order intended to modernize flu vaccines and help protect more Americ...

NDA to BLA List Updated

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FDA updates its preliminary list of approved NDAs that will be considered BLAs as of 3/23/20.

Guide on Drug Distributor Verification Requirement

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable...