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Genesis Medical Sellng Unapproved Adipose Cellular Products: FDA

[ Price : $8.95]

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

AdvaMed Comments on FDA Device Remanufacturing Guidance

[ Price : $8.95]

AdvaMed says an FDA draft guidance on remanufacturing of medical devices should clarify the difference between remanufacturing and...

FDA OKs Baxters Premix Norepinephrine

[ Price : $8.95]

FDA approves Baxters premix norepinephrine bitartrate in 5% dextrose injection, indicated for raising blood pressure in adult pati...

Guide on GMPs for Animal Cell, Tissue Products

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Federal Register notice: FDA makes available a draft guidance for industry #253 entitled Good Manufacturing Practices for Animal C...

Donor Eligibility Guide for Animal Cell, Tissue Products

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Federal Register notice: FDA announces the availability of a draft guidance for industry #254 entitled Donor Eligibility for Anima...

Workshop on Orthopedic Device-Related Infections

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

CGMP, Other Violations at Furley Bioextracts

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FDA warns Malaysias Furley Bioextracts about CGMP violations in its production of OTC drugs and manufacturing a misbranded unappro...

CGMP Violations at Laboratorio Pharma International

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FDA warns Honduras Laboratorio Pharma International about significant CGMP violations in its manufacturing of OTC drugs and produc...

Court Nixes FDA Compounding MOU with States

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The DC federal court says FDA failed to prepare a necessary regulatory flexibility analysis when it developed a Final Standard Mem...

FDA Goals for BsUFA 3 Released

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FDA releases the Biosimilar User Fee Act reauthorization goal letter for FY 2023-2027.