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FDA took new steps to mitigate shortages of EpiPen (epinephrine) auto-injector marketed by Mylan by extending the expiration date of specific lots by four months... [Read More]
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world... [Read More]
The U.S. Food and Drug Administration alerts consumers and retailers of the potential for serious injury from eating, drinking, or handling food products prepared by... [Read More]
The U.S. Food and Drug Administration alerts consumers and retailers of the potential for serious injury from eating, drinking, or handling food products prepared by... [Read More]
FDA took new steps to mitigate shortages of EpiPen (epinephrine) auto-injector marketed by Mylan by extending the expiration date of specific lots by four months... [Read More]
FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval... [Read More]
FDA is alerting dog owners and veterinarians about the risk of accidental overdose to dogs treated with the drug Sileo, a prescription gel that is... [Read More]
FDA reports on additional deaths in patients with two balloon devices, the Orbera Intragastric Balloon system and ReShape Integrated Dual Balloon system... [Read More]
FDA warns of fraudulent and unapproved flu products... [Read More]
Allows retrieval from database containing the import refusal data of the last year... [Read More]
Overview of Issues                                                    Debra B. Birnkrant, M.D. [Read More]
One of the simplest ways patients can make daily decisions that have lasting impact is by using the Nutrition Facts Label (NFL) on food and... [Read More]
FDA may require a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that the benefits of certain drugs outweigh their risks. FDA Drug Info... [Read More]
In 1976, President Ford signed the Medical Device Amendments that closed the dangerous gap between what he called FDA's "horse and buggy authority" and "laser... [Read More]
For the "Year of Clinical Trial Diversity", FDA is launching a series of educational videos and materials to raise awareness about the importance of minorities... [Read More]
For the "Year of Clinical Trial Diversity", FDA is launching a series of educational videos and materials to raise awareness about the importance of minorities... [Read More]
For the "Year of Clinical Trial Diversity", FDA is launching a series of educational videos and materials to raise awareness about the importance of minorities... [Read More]
For the "Year of Clinical Trial Diversity", FDA is launching a series of educational videos and materials to raise awareness about the importance of minorities... [Read More]
For the "Year of Clinical Trial Diversity", FDA is launching a series of educational videos and materials to raise awareness about the importance of minorities... [Read More]
For patients suffering from life-threatening conditions and who have few, if any, options, this access becomes critical. About a year ago, FDA's Center for Devices... [Read More]
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