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The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (), nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aimed to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries.
Kessler was the commissioner of the Food and Drug Administration (FDA) from November 8, 1990, to February 28, 1997. He co-chaired the Biden-Harris transition’s COVID-19 Advisory Board from November 2020 to January 2021 and was the head of Operation Warp Speed , the U.S. government program to accelerate the development of COVID-19 vaccines and ...
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Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company as an anti-inflammatory arthritis drug. [3] It was approved by the United States Food and Drug Administration (FDA) on November 20, 2001, to treat arthritis and menstrual cramps, [ 4 ] [ 5 ] and was available by prescription in tablet form until 2005 ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
Few periods of life are more closely monitored and supervised than during one's pregnancy. Throughout this time, trained medical professionals conduct a series of prenatal visits with the mother ...
The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV. The complete list of Schedule V substances is as follows.
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of Pub. L. 109–148 (text)), is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency.