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Central Admixture FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.

FDA Hits Medical Device Intended Use Creep

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Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is...

Voluntary Consensus Standards Guidance

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FDA issues a final guidance describing CDERs program for the recognition of voluntary consensus standards related to drug quality....

Octapharma NDA for Warfarin Reverser OKd

[ Price : $8.95]

FDA approves an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation fact...

Abbott Recalls Amplatzer Delivery Sheath

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Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients und...

Defender Pharma NDA for Scopolamine Gel

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Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vo...

Alert Update on Vessel Occlusion CADt Devices

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An FDA update clarifies the intended use of radiological computer-aided triage and notification devices for intracranial large ves...

Fentanyl Detection Kit Gains Clearance

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FDA clears a Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human u...

Dismissal Sought in FDA-483 Anonymity Suit

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FDA says that a reverse-FOIA lawsuit seeking to shield an unnamed company attorneys identity in connection with a Form FDA-483 sho...

3rd Circuit Flunks FDA Again Over Illegal Generics

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The 3rd Circuit Court of Appeals agrees with a Pennsylvania federal court that FDA failed to state the offense under the law in ch...