FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues

FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues

Company must cease manufacturing until corrective action is taken 

U. S. District Judge Denise J. Casper entered a consent decree of permanent injunction yesterday between the U.S. and Philips North America LLC (doing business as Philips Medical Systems and Philips Healthcare) of Andover, Massachusetts, and two of the company’s officers, Carla Kriwet, business group leader for the Patient Care and Monitoring Solutions (PCMS) business group, and Ojas Buch, vice president, head of quality and regulatory for PCMS. The PCMS business group includes the Emergency Care and Resuscitation (ECR) business unit, which markets automatic external defibrillators (AEDs) and Q-CPR Meters. Continue reading.

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“DRUG REG AFFAIRS INT” CATERS TO EDUCATION GLOBALLY, No commercial exploits are done or advertisements added by me. This is a compilation for educational purposes only. P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent

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FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

 

As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes. Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective. The deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.Continue reading .

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FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections 

 

FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections 

 

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom. Continue reading.