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Latest FDA News and Information

Illinois food company agrees to stop production of contaminated sprouts

On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia... read more

FDA approves first-of-its-kind corneal implant to improve near vision in certain patients

The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in... read more

FDA approves first generic Copaxone to treat multiple sclerosis

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

U.S. Marshals seize unapproved drugs from Florida distributor

At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida, U.S. Marshals seized unapproved prescription drug products... read more

Food and Drug Adminstration (FDA): CDRHNew

Class I Medical Device Recall: LuSys Laboratories, Inc., Ebola Virus One-Step Test Kits - Not Cleared for Marketing

The FDA has not cleared or approved the Ebola Virus One-Step Test Kits for use or sale. The results obtained from these test kits have not demonstrated to be accurate... read more

Meeting Materials posted for April 30 - May 1, 2015 Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee

Meeting Materials posted for April 30 - May 1, 2015 Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee

Posted Presentations and Webcast to Public Workshop - An Interactive Discussion on the Clinical Considerations of Risk in the Post market Environment - April 21, 2015

The purpose of the workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket... read more

Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness... read more

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