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Human Drugs

IntegraDose Compounding Recalls 11 Cefazolin Lots

IntegraDose Compounding Services recalls nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0...

Medical Devices

Reverse CA Decision Punishing Scientific Speech: WLF

Washington Legal Foundation says the California Court of Appeals should reverse a trial court decision imposing $344 million in civil penalties on Eth...

Biologics

Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA

FDA cautions Genesis Medical Center that it is marketing unapproved cellular and exosome products.

Medical Devices

AdvaMed Comments on FDA Device Remanufacturing Guidance

AdvaMed says an FDA draft guidance on remanufacturing of medical devices should clarify the difference between remanufacturing and servicing to help t...

Human Drugs

FDA OKs Baxters Premix Norepinephrine

FDA approves Baxters premix norepinephrine bitartrate in 5% dextrose injection, indicated for raising blood pressure in adult patients with severe, ac...

Federal Register

Advisory Panel to Discuss Reata Pharma NDA

Federal Register notice: FDA announces a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting to discuss a Reata Pharmaceuticals NDA for its...

Biologics

CDC Backs Most of FDA EUA for Covid Booster

A CDC advisory panel recommends most of FDAs just-amended emergency use authorization (EUA) for Pfizer-BioNTechs Covid-19 vaccine booster, leaving off...

Federal Register

Guide on GMPs for Animal Cell, Tissue Products

Federal Register notice: FDA makes available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal Cells, Tissues, and C...

Federal Register

Donor Eligibility Guide for Animal Cell, Tissue Products

Federal Register notice: FDA announces the availability of a draft guidance for industry #254 entitled Donor Eligibility for Animal Cells, Tissues, an...

Medical Devices

Workshop on Orthopedic Device-Related Infections

FDA announces a 12/3 virtual public workshop entitled Orthopedic Device-Related Infections II Workshop.