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https://www.fda.gov/Drugs/DrugSafety/MedicationErrors/ucm253718.htm
Jan 09, 2015 · On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency’s recommendations for improving dosage delivery devices, such as cups and ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues
FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, respectively.
https://www.mddionline.com/whats-latest-drug-delivery-devices
May 22, 2019 · Resnick: FDA’s Office of Combination Products (OCP) will decide whether the product is a drug or a device, at which point CDER covers drug and CDRH reviews device. The issue is that depending on the route of review, a combination product may be reviewed by a regulator who is more familiar with the drug product than the device, so ...
https://promedmolding.com/implantable-drug-delivery-devices-overview/
Dec 18, 2017 · Implantable drug delivery devices offer several advantages over conventional oral or parenteral dosage forms. First, implantable devices allow site specific drug administration where the drug is most needed. Examples include implants used in the treatment of brain tumors (Gliadel® wafer) or prostate cancer (Lupron® depot).
https://www.meddeviceonline.com/doc/a-primer-on-investigational-drug-delivery-device-regulatory-requirements-0001
Nov 16, 2015 · The device part of a drug/ delivery system submissions needs to comply to the device requirements for investigational devices – with a few other common sense considerations. Combination drug/device delivery products are becoming the standard of care in many therapeutic areas.
https://www.mddionline.com/designing-drug-delivery-device-read-first
Jul 22, 2019 · Prefilled syringe or delivery device should be easy to use and injection should be less painful to the patient. Solution: While designing the drug delivery device, there are two sub-systems needs to be taken into consideration. One is the primary container system, which directly comes in contact with the drug formulation.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2593
Device: warmer, infant radiant: Regulation Description: ... Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C) Drug Delivery and General Hospital Devices, and Human Factors (DHT3C) Submission Type: 510(k) ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For Government; For Press; Combination ...
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=2827
Device: infusion pump, drug specific, pharmacy-filled: Regulation Description: Infusion pump. Definition: A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and …
https://www.marketwatch.com/press-release/aptar-pharmas-bidose-nasal-drug-delivery-device-approved-byus-fda-for-breakthrough-treatment-of-depression-2019-03-18
Mar 18, 2019 · Aptar Pharma, a leading drug delivery systems provider, is pleased to announce that its Bidose nasal spray device was recently approved by the U.S. FDA for a …
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