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CDER Quality Office Reorganizing Next Year

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CDER announces a reorganization of the Office of Pharmaceutical Quality effective 1/14/2024.

BD Mesh Products Alert on Breast Surgery

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FDA tells healthcare providers about labeling updates to Becton Dickinsons (BD) Phasix and GalaFlex mesh products that discourage ...

FDA Approves Recor Paradise System

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FDA approves a PMA for the Recor Medical Paradise renal denervation system to treat hypertension.

CareFusion Recalls Alaris Pump Module

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Becton Dickinsons CareFusion unit recalls its Alaris Patient Controlled Analgesia infusion pump module 8120 because the compatible...

Dont Approve Amryts Filsuvez NDA: Petition

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A Lassman Law petition filed for an unidentified client asks FDA not to approve an Amryt NDA for Filsuvez to treat cutaneous manif...

Compliance Delay on Cosmetic Registration

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Federal Register notice: FDA makes available a guidance entitled Compliance Policy for Cosmetic Product Facility Registration and ...

Former Reviewer McGarry Joins Greenleaf Health

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Former FDA reviewer Sarah McGarry joins consulting firm Greenleaf Health as senior vice president of drug and biological products.

Rexulti Ads False and Misleading: OPDP

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The CDER Office of Prescription Drug Promotion says two Otsuka Rexulti ads contain misleading presentations of the drugs efficacy....

Lilly Obesity Drug Gains FDA Approval

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FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who ...

Support for Convalescent Plasma Registries

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CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent pla...