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FDA Information on Immune Globulin Shortage

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FDA says it is working in several ways with manufacturers to try to mitigate the current shortage of immune globulin products.

Pfizer Recalls 2 Relpax Lots

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FDA says Pfizer has recalled two lots of its migraine drug Relpax because they may not meet the company microbiological specificat...

Breakthrough Designation for Heart Failure Shunt

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FDA grants V-Wave a breakthrough device designation for its interatrial shunt for heart failure.

FDA Updating Inactive Ingredient Database

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FDA describes updates it will make to the inactive ingredient database as required under GDUFA 2.

New Approach to Expedited Drugs Needed: New York Times

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A New York Times editorial suggests three steps to address problems arising in expedited drug approvals, including extremely high ...

Info Collection on Device Sterilization Agreements

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Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Steri...

FDA, Syapse Doing RWE Regulatory Research

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FDA and Syapse announce a multi-year research effort to look at use of real-world evidence in oncology regulatory decisions.

Draft Guide on Gastroparesis Drug Development

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Federal Register notice: FDA posts a draft guidance on gastroparesis drug development.

Guide on Drug Labeling About Child Packaging

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Federal Register notice: FDA makes available a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeli...

Post Questions FDA Role in AI/ML Oversight

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Forbes Technology Council member Charles Aunger questions whether FDA is able to provide needed oversight of artificial intelligen...