New US Food and Drug Administration Approvals Decrease Generic Flucytosine Costs
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منابع مشابه
The US Food and Drug Administration and probiotics: regulatory categorization.
Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended to be used will govern the regulatory category or categories that the US Fo...
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BMJ VOLUME 329 4 DECEMBER 2004 bmj.com The US Food and Drug Administration, rocked by controversy in recent months, has now admitted that a senior management official secretly contacted a whistleblower group. That official attempted to discredit Dr David Graham, the FDA’s scientist who criticised the agency during US Senate hearings, saying that the FDA failed to protect the public when it appr...
متن کاملUS Food and Drug Administration Perspectives on Clinical Mass Spectrometry.
Mass spectrometry-based in vitro diagnostic devices that measure proteins and peptides are underutilized in clinical practice, and none has been cleared or approved by the Food and Drug Administration (FDA) for marketing or for use in clinical trials. One way to increase their utilization is through enhanced interactions between the FDA and the clinical mass spectrometry community to improve th...
متن کاملNew food safety initiatives in the Food and Drug Administration.
Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has be...
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NEW DRUG APPROVALS Opdivo for Melanoma Nivolumab injection (Opdivo, BristolMyers Squibb) has received the FDA’s accelerated approval for the treatment of patients with unresectable or metastatic melanoma that has progressed after treatment with specific medications. Nivolumab is a monoclonal antibody that binds to the programmed death-1 (PD-1) receptor and blocks its interaction with ligands PD...
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ژورنال
عنوان ژورنال: Clinical Infectious Diseases
سال: 2019
ISSN: 1058-4838,1537-6591
DOI: 10.1093/cid/ciz037