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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 the United States, a boxed warning (sometimes "black box warning", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize its ...
A New England Compounding Center meningitis outbreak that began in September 2012 sickened 798 individuals and resulted in the deaths of more than 100 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 ...
Natus Comments on FDA Recall SAN CARLOS, Calif.--(BUSINESS WIRE)-- Natus Medical Incorporated (NAS: BABY) today released a statement regarding the issuance by the Food & Drug Administration (the ...
A drug can have perfect efficacy and safety, but if the Food and Drug Administration has an issue with the manufacturing of the drug, it's not going to be What to Make of This FDA Rejection Skip ...
The FDA gave the company 15 working days to respond to the warning letter. This article originally appeared on Milwaukee Journal Sentinel: Brenntag Great Lakes receives FDA warning letter over ...
Transvaginal mesh, also known as vaginal mesh implant, is a net-like surgical tool that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) among female patients. The surgical mesh is placed transvaginally to reconstruct weakened pelvic muscle walls and to support the urethra or bladder. [1] [2]
Investors' blood pressure might be on the rise today, but it isn't because they're taking Chelsea Therapeutics' (NAS: CHTP) Northera. Yesterday, the Food and Drug Administration rejected the drug ...