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Human Drugs

Vyaire Medical Recall Twin Tube Lines

Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for ...

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Federal Register

Draft Guide on Vet Drug Residues

Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human...

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Medical Devices

IDE for Brain Interchange Implant in Stroke Therapy

FDA approves a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Brain Interchange Impl...

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Federal Register

Evaluating Immunosuppressive Effects in Drugs Workshop

Federal Register notice: FDA announces a 7/11 public workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic ...

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Federal Register

Comments Extended on Animal Drug Labeling Rule

Federal Register notice: FDA extends the comment period on its proposed rule entitled Labeling Requirements for Approved or Conditionally Approved New...

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Human Drugs

Otsuka Scraps Alzheimers Agitation Drug

Based on disappointing Phase 3 trial data, Otsuka Pharmaceutical terminates its development of the novel compound AVP-786 as a potential treatment for...

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Medical Devices

Panel Views Asked on Shield Colorectal Cancer Screen

FDA asks an advisory panel to vote on the safety and effectiveness of the Guardant Shield colorectal screening test for use with patients at average r...

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Federal Register

CDRH Seeks Non-voting Industry Panel Reps

Federal Register notice: FDA requests that any industry organizations interested in participating in the selection of nonvoting industry representativ...

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Medical Devices

AdvaMed Ideas to Help ASCA Achieve its Promise

AdvaMed makes five suggestions to help FDA improve revised Accreditation Scheme for Conformity Assessment guidances.

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Human Drugs

Hypoglycemia Risk in Novos Weekly Insulin: FDA

FDA medical reviewers share with the Endocrinologic and Metabolic Drugs Advisory Committee their concerns about an increased risk of hypoglycemia in T...