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Vivos Sleep Apnea Device Cleared

[ Price : $8.95]

FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating...

FDA Still Evaluating Left Atrial Occlusion Implants

[ Price : $8.95]

FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing ...

New Theories of False Claims Act Liability

[ Price : $8.95]

A lengthy online newsletter written by several Skadden attorneys explores possible new theories of cybersecurity False Claims Act ...

Regenerative Medicine Consensus Standards Guide

[ Price : $8.95]

FDA publishes a guidance describing CBERs standards recognition program for regenerative medicine therapies.

Similar Intas CGMP Violations

[ Price : $8.95]

FDA warns Intas Pharmaceuticals about repeat CGMP violations at its drug manufacturing facility in Matoda-Sanand, Ahmedabad, India...

Korsuva Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Cara Therapeutics Korsuva (...

Cosela Regulatory Review Period

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for G1 Therapeutics Cosela (tr...

Info Collection on Device Shortages Data

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Shortages Data Collections.

Serious Reaction to Some Anti-Seizure Meds: FDA

[ Price : $8.95]

FDA warns of a rare but serious risk of Drug Reaction with Eosinophilia and Systemic Symptoms associated with two anti-seizure dru...

Acelyrin Auditing Izokibep Trial Issues

[ Price : $8.95]

Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.