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Janet Woodcock
Janet Woodcock (born August 29, 1948) is an American physician and former Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021. Woodcock has overseen the modernization and streamlining of CDER and FDA, introducing new initiatives to improve the timeliness and transparency of FDA procedures, and the safety, quality and effectiveness of drugs. She informs the United States Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation. In 2015, Woodcock received a Lifetime Achievement Award from the Institute for Safe Medication Practices in recognition of “a significant career history of making ongoing contributions to patient safety.” She has also received the 2019 Biotechnology Heritage Award. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Commissioner Of Food And Drugs
The United States Commissioner of Food and Drugs is the head of the Food and Drug Administration (FDA), an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States and must be confirmed by the Senate. The commissioner reports to the Secretary of Health and Human Services. Due to frequent controversies involving the FDA, appointments are not always prompt and the agency is often headed by an acting commissioner. For example, Andrew von Eschenbach's appointment was held up by senators who objected to the FDA's refusal to allow emergency contraception to be sold over the counter. The commissioner has frequently been a physician, but this is not a requirement for the post. Commissioners rarely come from a food-related background. List of commissioners ''Unnumbered, colored rows indicate acting commissioners.'' See also * Regulation of therapeutic goods References {{FDA commissioners Commissioners ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pennsylvania State University
The Pennsylvania State University (Penn State or PSU) is a Public university, public Commonwealth System of Higher Education, state-related Land-grant university, land-grant research university with campuses and facilities throughout Pennsylvania. Founded in 1855 as the Farmers' High School of Pennsylvania, Penn State became the state's only Land-grant university, land-grant university in 1863. Today, Penn State is a major research university which conducts teaching, research, and public service. Its instructional mission includes undergraduate, graduate, professional and continuing education offered through resident instruction and online delivery. The University Park campus has been labeled one of the "Public Ivy, Public Ivies", a publicly funded university considered as providing a quality of education comparable to those of the Ivy League. In addition to its land-grant designation, it also participates in the sea-grant, space-grant, and sun-grant research consortia; it is on ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration Amendments Act Of 2007
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. The FDAAA extended the authority to levy fees to companies applying for approval of drugs, expanded clinical trial guidelines for pediatric drugs, and created the priority review voucher program, amongst other items. Title I: Prescription Drug User Fee Amendments of 2007 Title I amends the Federal Food, Drug, and Cosmetic Act to include post-marketing safety activities in the review of drug application. This included developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety probl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Sentinel Initiative
Sentinel Initiative is a set of efforts by U.S. Food and Drug Administration (FDA) that tries to improve the ability to identify and evaluate safety of medicinal products. It has several parts: Sentinel System, Postmarket Rapid Immunization Safety Monitoring (PRISM) system, and Blood Safety Continuous Active Surveillance Network (BloodSCAN). Part of Sentinel Initiative is a surveillance program for biologics. It is called Biologics Effectiveness and Safety (BEST) Initiative. Sentinel System The Sentinel System uses pre-existing electronic healthcare data (including billing data). Part of the Sentinel System is a tool called Active Postmarket Risk Identification and Analysis (ARIA) system that was mandated in the U.S. Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007. See also * Health informatics * Real world data * Real world evidence Real-world evidence (RWE) in medicine is the clinical evidence regarding the usage and potential benefits or risks of a medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine Adverse Event Reporting System
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine. VAERS, the Vaccine Safety Datalink, and the Clinical Immunization Safety Assessment (CISA) Network are tools by which the CDC and FDA monitor vaccine safety to fulfill their duty as regulatory agencies charged with protecting the public. As it is based on submissions by the public, VAERS is susceptible to unverified reports, misattribution, underreporting, and inconsistent data quality. Raw, unverified data from VAERS has often been used by the anti-vaccine community to justify misinformation ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Adverse Event Reporting System
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses FAERS to monitor for new adverse events and medication errors that might occur with these products. It is a system that measures occasional harms from medications to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular drug and to identify correctable and preventable problems in health care delivery (such as need for retraining to prevent prescribing errors). The system interacts with several related systems including MedWatch and the Vaccine Adverse Event Reporting System. FAERS replaced legacy AERS system in Sep 2012. Background Reporting of adverse events from the point of care is voluntary in the United States. The FDA receives some adverse event and medicati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
John Dingell
John David Dingell Jr. (July 8, 1926 – February 7, 2019) was an American politician who served as a member of the United States House of Representatives from 1955 until 2015. A member of the Democratic Party, he holds the record for longest-serving member of Congress in American history, representing Michigan for more than 59 years. He most recently served as the representative for Michigan's 12th congressional district. A longtime member of the House Energy and Commerce Committee, Dingell was the chairman of the committee from 1981 to 1995 and 2007 to 2009. Born in Colorado Springs, Colorado, he attended Georgetown University as an undergraduate and law student. Dingell began his congressional career by succeeding his father, John Dingell Sr., as representative for on December 13, 1955; his father had held the seat for 22 years. He left office on January 3, 2015. Having served for over 59 years, he has the longest congressional tenure in U.S. history. Together with Jami ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cystic Fibrosis
Cystic fibrosis (CF) is a rare genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys, and intestine. Long-term issues include difficulty breathing and coughing up mucus as a result of frequent lung infections. Other signs and symptoms may include sinus infections, poor growth, fatty stool, clubbing of the fingers and toes, and infertility in most males. Different people may have different degrees of symptoms. Cystic fibrosis is inherited in an autosomal recessive manner. It is caused by the presence of mutations in both copies of the gene for the cystic fibrosis transmembrane conductance regulator (CFTR) protein. Those with a single working copy are carriers and otherwise mostly healthy. CFTR is involved in the production of sweat, digestive fluids, and mucus. When the CFTR is not functional, secretions which are usually thin instead become thick. The condition is diagnosed by a sweat test and genetic testing. Screening of infants at bi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Multiple Sclerosis
Multiple (cerebral) sclerosis (MS), also known as encephalomyelitis disseminata or disseminated sclerosis, is the most common demyelinating disease, in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to transmit signals, resulting in a range of signs and symptoms, including physical, mental, and sometimes psychiatric problems. Specific symptoms can include double vision, blindness in one eye, muscle weakness, and trouble with sensation or coordination. MS takes several forms, with new symptoms either occurring in isolated attacks (relapsing forms) or building up over time (progressive forms). In the relapsing forms of MS, between attacks, symptoms may disappear completely, although some permanent neurological problems often remain, especially as the disease advances. While the cause is unclear, the underlying mechanism is thought to be either destruction by the immune system ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Center For Biologics Evaluation And Research
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks (physician), Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologic medical product, biologics and related products (such as vaccines, live biotherapeutics (probiotics), blood products, and Cell therapy, cell, tissue, and Gene therapy, gene therapies). Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER). Scope * Blood for transfusion and as a raw material for drug products, as well as reagents used for blood typing and other related activities -and- Blood plasma, plasma derivatives, including intravenous immunoglobulin, immunoglobulins, Hy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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