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Info Collection for eRecords/Signatures

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Federal Register notice: FDA sends to OMB an information collection extension for Electronic Records; Electronic Signatures 21 CF...

Comments on Unit-of-Use Blister Packaging for Opioids

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Federal Register notice: FDA reopens the comment period for a 5/31/2019 notice entitled Fixed-Quantity Unit-of-Use Blister Packagi...

Multiple Dietary Supplement Violations at ForYou

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FDA warns dietary supplement manufacturer ForYou, Inc., about CGMP and other violations in its production and distribution of diet...

MDIC Forms 5G Healthcare Technology Working Group

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The Medical Device Innovation Consortium says it has launched a stakeholder working group to address 5G-enabled healthcare technol...

FDA Approves PET Imaging Prostate Cancer Drug

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FDA approves Gallium 68 PSMA-11 for use in PET imaging of prostate-specific membrane antigen in men with prostate cancer.

Company Selling Unapproved Home Covid Tests: FDA

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FDA warns Industry Lab Diagnostic Partners that it is distributing an unapproved home Covid-19 test kit.

Baxter Recalls Spectrum Infusion Pumps

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Baxter Healthcare recalls its Sigma Spectrum Infusion Pumps with Master Drug Library and the Baxter Spectrum IQ Infusion Systems w...

Genentech Gets New Indication for Xolair

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FDA approves a Genentech supplemental BLA for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult pa...

Guide on Gastric pH-Dependent Drug Interactions

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Federal Register notice: FDA makes available a draft guidance entitled Evaluation of Gastric pH-Dependent Drug Interactions With A...

Hahn Summoned to White House About Vaccine Delay

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President Trumps chief of staff Mark Meadows summons FDA commissioner Stephen Hahn to the White House 12/1 to learn why the agency...