Medical Devices
2 Vyaire Pulmonary Function Tests Cleared
FDA clears a Vyaire Medical 510(k) for two of its latest pulmonary function testing technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software...
Human Drugs
J&J Ordered to Pay $572 Million in Opioid Case
Oklahoma county judge Thad Balkman rules against Johnson & Johnson and orders it to pay $572 million in the first ruling in the U.S. holding a drugmak...
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/23/2019.
FDA General
Since Our last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/29/2014
Medical Devices
Miracor Heart Device Gains Breakthrough Status
FDA grants Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients.
Medical Devices
FDA Clears Drawbridge OneDraw A1C Device
FDA clears a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test.
Human Drugs
Warmer Pack Recalled Over Associated Device
Medline recalls its Primary Warmer Pack because it contains the recalled Vyaire Medical enFlow Disposable Cartridge.
Federal Register
Panel to Discuss Chikungunya Vaccine Development
Federal Register notice: FDA announces an 11/8 Vaccines and Related Biological Products Advisory Committee meeting to discuss chikungunya vaccine deve...
Human Drugs
Califf Airs Concerns About Zolgensma Data Lapse
Former FDA commissioner Robert Califf says the Novartis Zolgensma data integrity case shows the need for a well-funded and staffed FDA able to exercis...
