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FDA Inspection Council Holds 1st Meeting

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ACRA McMeekin announces FDA's first FDA Inspectional Affairs Council meeting this week to discuss optimizing agency inspections on...

White House, Senators Fighting Over FDA Head: CNN

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CNN reports that Janet Woodcock is no longer the front-runner to be named FDA commissioner due to concerns voiced by some Senate D...

3 CDER Officials Defend Aduhelm Approval

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Three top CDER officials say their decision to grant accelerated approval to Biogens Aduhelm was consistent with the requirements ...

OPDP to Ask Medical Professionals About Drug Promotion at Conferences

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The CDER Office of Prescription Drug Promotion plans to study how healthcare professionals respond to prescription drug exhibit bo...

Guide on Animal Drug Conditional Approval

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Federal Register notice: FDA makes available a final guidance entitled Eligibility Criteria for Expanded Conditional Approval of N...

EnsoData 510(k) for Sleep Apnea Device

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FDA clears an EnsoData 510(k) for new capabilities and enhancements to its EnsoSleep product, an artificial intelligence-assisted ...

Innoveix Pharma Recall of Sterile Products

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Innoveix Pharmaceuticals recalls several lots of sterile compounded drug products due to a lack of sterility assurance that was de...

Priority Voucher for Mallinckrodts Stratatech Unit

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Federal Register notice: FDA announces that it has issued a priority review voucher to Mallinckrodts Stratatech unit after approvi...

Info Collection on Device Labeling Regs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Device Labeling Regulations.

Guillain Barr Warning Added to J & J Vaccine

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FDA approves a new warning on Johnson & Johnsons Covid-19 vaccine about the risk of Guillain Barr syndrome.