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Sibel Health Infant Monitor Cleared

[ Price : $8.95]

FDA clears a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring.

Complete Response on Bladder Cancer BLA

[ Price : $8.95]

FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) ...

PhRMA on FDA Negative Controls Workshop

[ Price : $8.95]

Pharmaceutical Research and Manufacturers of America suggests things for FDA to consider as it moves forward from a March workshop...

CRN Asks FDA to Reconsider Drug Preclusion

[ Price : $8.95]

The Council for Responsible Nutrition asks FDA to reconsider how it uses the drug preclusion clause in the Dietary Supplement Heal...

Abbott MRI Labeling OKd for Spinal Stimulator

[ Price : $8.95]

FDA approves expanded Magnetic Resonance Imaging labeling for Abbotts Eterna spinal cord stimulation (SCS) system to include new l...

Study Data Technical Conformance Guide

[ Price : $8.95]

FDA publishes a Study Data Technical Conformance Guide with specifications, recommendations, and general considerations on how to ...

Stakeholder Ideas on FDA Electronic System Draft

[ Price : $8.95]

Four pharmaceutical stakeholders recommend changes to an FDA question-and-answer draft guidance on electronic systems, records, an...

FDA Wants Updated Labeling on Some Stimulants

[ Price : $8.95]

FDA orders safety labeling changes for prescription stimulants used to treat attention deficit/hyperactivity disorder and other co...

Panel to Discuss Pediatric Oncology Dose Optimization

[ Price : $8.95]

Federal Register notice: FDA announces a 6/16 Oncologic Drugs Advisory Committee meeting of its Pediatric Oncology Subcommittee th...

Guide on Drug Testing for Contaminants

[ Price : $8.95]

Federal Register notice: FDA releases a final guidance on drug testing for high-risk drug components.