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FDA finalizes guidance on use of human factors studies in combination product development

FDA finalizes guidance on use of human factors studies in combination product development
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Drug administrationRadiological healthBiologics evaluationDrug evaluationHuman factorsUsability engineeringProduct designMinimize medication errors

FDA Publishes Guidance For Biopharma Container Labels Carton Labeling Design

The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an.

Mark durivageInstitute of medicineInstitute for safe medication practicesDrug administrationQuality systems complianceNational patient safety agencyDrug evaluationBiologics evaluationSafety considerationsContainer labelsCarton labeling designMinimize medication errors guidancePreventing medication errorsLabeling considerationsGeneral biological products standardsUnited states pharmacopeia

Former FDA DMEPA Director and Head of Brand Institute s Regulatory Division Updates the Company s Services Based on Recent FDA Safety Guidance

/PRNewswire/ Brand Institute, the global leader in pharmaceutical and healthcare related name development, is pleased to announce incorporation of the.

United statesJames dettoreDrug safety instituteBrand instituteOffice of surveillanceDivision of medication error preventionCommission patient safety advisory groupDrug administrationNational coordinating council for medication errorBrand institute incInternational medication safety networkPrnewswire brand instituteHealth canadaTodd bridgesSafety considerationsContainer labels

FDA Publishes Guidance For Biopharma Container Labels Carton Labeling Design

The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an.

Mark durivageInstitute of medicineInstitute for safe medication practicesDrug administrationQuality systems complianceNational patient safety agencyDrug evaluationBiologics evaluationSafety considerationsContainer labelsCarton labeling designMinimize medication errors guidancePreventing medication errorsLabeling considerationsGeneral biological products standardsUnited states pharmacopeia

Redesigned bottle adapter promotes dosing safety

The DoseGuard bottle adapter from Comar Comar, an original member of the safe dosing initiative PROTECT, is launching a new version of its DoseGuard for easier integration into drug packaging. The company will be showcasing the new design at Booth #2871 during EastPack June 14-16, and Comar’s Russ Granato will be speaking in a panel discussion on PROTECT June 16. DoseGuard is a bottle adapter featuring a valve (shown above) that remains closed until the tip of an oral syringe is inserted. When the syringe is removed, the valve closes to resecure the liquid medicine. The new low-profile design allows drug manufacturers to use a standard bottle and closure with no special modifications. “They can use what they already have,” reports LouAnn Evans, Director of Strategic Marketing at Comar. “The original design required a modified bottle neck and a modified syringe, and it only worked with select resins. The new product is compatible with a wider range of materials.”

Louann evansComar russ granatoEastpack juneRuss granatoStrategic marketingProduct designMinimize medication errorsலௌஉன்ங் எவன்ஸ்கோமர் ரஸ் கிரானடோரஸ் கிரானடோமூலோபாய சந்தைப்படுத்தல்ப்ராடக்ட் வடிவமைப்பு

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