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FDA Clears eNeura Expanded Use for Migraine Device

[ Price : $8.95]

FDA clears an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache.

Separate Kayexalate from Other Oral Meds: FDA

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FDA recommends patients not take Kayexalate and other oral medicines at the same time to prevent reducing the effectiveness of the...

PharMedium Recalls Compounded Oxytocin

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PharMEDium Services recalls all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin com...

OmniLife Robotic Tissue Balancer Cleared

[ Price : $8.95]

FDA clears an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the companys OmniBotics rob...

Court Gives Device Whistleblower Another Chance

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Attorney Jennifer Thomas says a Boston Scientific whistleblower given a green light to refile a suit may have difficulty demonstra...

Novo Nordisk Paying $58 Million in Whistleblower Cases

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The Justice Department says Novo Nordisk is paying more than $58 million to resolve False Claims Act and Federal Food, Drug, and C...

Guidance on Interoperable Medical Devices

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Federal Register notice: FDA makes available a guidance on Design Considerations and Pre-market Submission Recommendations for Int...

12 Observations in Korea Celltrion Inspection

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FDA releases an FDA-483 with 12 inspection observations from Koreas Celltrion drug manufacturing facility.

Recommended Hep A GamaSTAN Dose Increased

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FDA recommends an increased dosage of GamaSTAN S/D when used for hepatitis A prophylaxis.

HCT/P Deviation Reporting Guidance Out

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FDA publishes a guidance to help manufacturers of certain specified human cells, tissues, and cellular and tissue-based products r...