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A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of 64 people. [2] [3] [4] In September 2012, the Centers for Disease Control and Prevention, in collaboration with state and local health departments and the Food and Drug Administration (FDA), began investigating a multistate outbreak of fungal meningitis and ...
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
In April 2005, FDA advisors requested that Pfizer place a boxed warning on their non-steroidal anti-inflammatory drug Celebrex for cardiovascular and gastrointestinal risks. [9] [10] In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was ...
A recent example in the news was the advisory committee recommendation that the FDA approve Truvada, made by Gilead Sciences (NAS: GILD) , for use in treating HIV pre-exposure prophylaxis.
The decision marked the second time Barker has blocked the FDA's warning label rule. In 2022, the judge concluded the requirement violated the companies' speech rights under the U.S. Constitution ...
The U.S. National Highway Traffic Safety Administration said on Monday it is upgrading a probe into 129,222 Ford Motor vehicles over reports of collisions involving the company's hands-free ...
An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as:
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