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Company Warned Over Human Placenta Product

FDA tells MiMedx that its wound-healing product must be regulated as a biologic

United statesJoseph capperBarlett steeleKristina fiorePaul knoepflerPublic health serviceGen active labMimedx groupUniversity of california davisDepartment of veterans affairsUs department of justiceCalifornia davisMedpage todayVeterans affairsSignature biologicsStratus biosystems

Trends In FDA FY2022 Inspection-based Warning Letters

We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a.

United statesPuerto ricoWladyslaw retterVasyl melnykKalah auchinclossJosepha zadraRichardj obisoLas vegasSmithac reddyLiz oestreichDaniel fred goodmanDanielc tarquinoGlicerinas industrialesDanielc tarquinioMadeleine giaquintoSabines hazan

Trends In FDA FY2022 Inspection-based Warning Letters

We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a.

United statesPuerto ricoWladyslaw retterVasyl melnykKalah auchinclossJosepha zadraRichardj obisoLas vegasSmithac reddyLiz oestreichDaniel fred goodmanDanielc tarquinoGlicerinas industrialesDanielc tarquinioMadeleine giaquintoSabines hazan

FDA Getting Tougher on Birth Tissue Companies

Agency calls out manufacturer on orthopedic indications

United statesLeigh turnerChris centenoKristina fiorePaul knoepflerBarlett steeleUniversity of california davisUtah cord bankGen active labUniversity of california irvineRe gen active labCalifornia davisRe gen active labsIdaho based smart surgicalPredictive biotechCalifornia irvine

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