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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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

12 Observations in Korea Celltrion Inspection

[ Price : $8.95]

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

Recommended Hep A GamaSTAN Dose Increased

[ Price : $8.95]

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

HCT/P Deviation Reporting Guidance Out

[ Price : $8.95]

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

Public Meeting on Grandfathered Dietary Supplements

[ Price : $8.95]

Federal Register notice: FDA announces a 10/3 public meeting entitled Development of a List of Pre-DSHEA Dietary Ingredients.

Ritalin NDA Not Withdrawn Due to Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsul...

Gynorest Not Withdrawn Due to Safety/Effectiveness: FDA

[ Price : $8.95]

Federal Register notice: FDA determines that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 ...