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Vyaire Medical Recall Twin Tube Lines

[ Price : $8.95]

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

Draft Guide on Vet Drug Residues

[ Price : $8.95]

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

IDE for Brain Interchange Implant in Stroke Therapy

[ Price : $8.95]

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

Comments Extended on Animal Drug Labeling Rule

[ Price : $8.95]

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

Otsuka Scraps Alzheimers Agitation Drug

[ Price : $8.95]

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

Panel Views Asked on Shield Colorectal Cancer Screen

[ Price : $8.95]

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

CDRH Seeks Non-voting Industry Panel Reps

[ Price : $8.95]

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

AdvaMed Ideas to Help ASCA Achieve its Promise

[ Price : $8.95]

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

Hypoglycemia Risk in Novos Weekly Insulin: FDA

[ Price : $8.95]

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

Harpreet Singh Leaves FDA for Precision Medicine

[ Price : $8.95]

FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.