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Janet Woodcock
Janet Woodcock (born August 29, 1948) is an American physician who served as Principal Deputy Commissioner of Food and Drugs from February 2022 until February 2024, having previously served as 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 histo ... [...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 A physician, medical practitioner (British English), medical doctor, or simply doctor is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through the Medical education, study, Med ..., but this is not a requi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Joe Biden
Joseph Robinette Biden Jr. (born November 20, 1942) is an American politician who was the 46th president of the United States from 2021 to 2025. A member of the Democratic Party (United States), Democratic Party, he served as the 47th vice president of the United States, vice president from 2009 to 2017 and represented Delaware in the U.S. Senate from 1973 to 2009. Born in Scranton, Pennsylvania, Biden graduated from the University of Delaware in 1965 and the Syracuse University College of Law in 1968. He was elected to the New Castle County Council in 1970 and the 1972 United States Senate election in Delaware, U.S. Senate in 1972. US Senate career of Joe Biden, As a senator, Biden chaired the Senate United States Senate Committee on the Judiciary, Judiciary Committee and United States Senate Committee on Foreign Relations, Foreign Relations Committee. He drafted and led passage of the Violent Crime Control and Law Enforcement Act and the Violence Against Women Act. He also ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Feinberg School Of Medicine
The Northwestern University Feinberg School of Medicine, formerly Northwestern Medical School from 1906 to 2002, is the medical school of Northwestern University and is located in the Streeterville neighborhood of Chicago, Illinois. Founded in 1859, Feinberg offers a full-time Doctor of Medicine degree program, multiple dual degree programs, graduate medical education, and continuing medical education. Through clinical affiliates Northwestern Memorial Hospital, the Ann & Robert H. Lurie Children's Hospital of Chicago, and the Shirley Ryan AbilityLab (formerly Rehabilitation Institute of Chicago). Feinberg and its clinical affiliates are together an $11 billion academic medical enterprise. The school has about 4,830 faculty members. Academic Medical Center The Feinberg School of Medicine is part of the McGaw Medical Center of Northwestern University. Other McGaw members include: * Ann & Robert H. Lurie Children's Hospital of Chicago * Northwestern Memorial Hospital * S ... [...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] |
MedWatch
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with the medical community or the general public. The system includes publicly available databases and online analysis tools for professionals. MedWatch also distributes information on medical recalls and other clinical safety communications via its platforms. History MedWatch was founded in 1993 to collect data regarding adverse events in healthcare. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, ... [...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 medica ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Risk Management
Risk management is the identification, evaluation, and prioritization of risks, followed by the minimization, monitoring, and control of the impact or probability of those risks occurring. Risks can come from various sources (i.e, Threat (security), threats) including uncertainty in Market environment, international markets, political instability, dangers of project failures (at any phase in design, development, production, or sustaining of life-cycles), legal liabilities, credit risk, accidents, Natural disaster, natural causes and disasters, deliberate attack from an adversary, or events of uncertain or unpredictable root cause analysis, root-cause. Retail traders also apply risk management by using fixed percentage position sizing and risk-to-reward frameworks to avoid large drawdowns and support consistent decision-making under pressure. There are two types of events viz. Risks and Opportunities. Negative events can be classified as risks while positive events are classifi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
John Dingell
John David Dingell Jr. ( ; July 8, 1926 – February 7, 2019) was an American politician from the state of Michigan who served as a member of the United States House of Representatives from 1955 until 2015. A member of the Democratic Party, Dingell holds the record as the longest-serving member of Congress in American history. Born in Colorado Springs, Colorado, Dingell attended Georgetown University, where he earned a Bachelor of Science in chemistry in 1949 and a Juris Doctor in 1952. Dingell began his congressional career by succeeding his father, John Dingell Sr., as representative for on December 13, 1955. A longtime member of the House Energy and Commerce Committee, Dingell chaired the committee from 1981 to 1995 and from 2007 to 2009. He was Dean of the House of Representatives from 1995 to 2015. Dingell was instrumental in the passage of the Medicare Act, the Water Quality Act of 1965, the Clean Water Act of 1972, the Endangered Species Act of 1973, the Clean Ai ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder inherited in an autosomal recessive manner that impairs the normal clearance of Sputum, mucus from the lungs, which facilitates the colonization and infection of the lungs by bacteria, notably ''Staphylococcus aureus''. CF is a rare genetic disorder that affects mostly the lungs, but also the pancreas, liver, kidneys, and intestine. The hallmark feature of CF is the accumulation of thick mucus in different organs. Long-term issues include Shortness of breath, difficulty breathing and coughing up mucus as a result of frequent pneumonia, lung infections. Other signs and symptoms may include Sinusitis, sinus infections, failure to thrive, poor growth, Steatorrhea, fatty stool, Nail clubbing, 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 (alleles) ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Multiple Sclerosis
Multiple sclerosis (MS) is an autoimmune disease resulting in damage to myelinthe insulating covers of nerve cellsin the brain and spinal cord. As a demyelinating disease, MS disrupts the nervous system's ability to Action potential, transmit signals, resulting in a range of signs and symptoms, including physical, cognitive disability, mental, and sometimes psychiatric problems. Symptoms include double vision, vision loss, eye pain, muscle weakness, and loss of Sensation (psychology), 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 relapsing forms of MS, symptoms may disappear completely between attacks, although some permanent neurological problems often remain, especially as the disease advances. In progressive forms of MS, bodily function slowly deteriorates once symptoms manifest and will steadily worsen if left untreated. While its cause is unclear, ... [...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 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 Vinay Prasad, M.D., M.P.H. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products (such as vaccines, live biotherapeutics ( probiotics), blood products, and cell, tissue, and 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- plasma derivatives, including immunoglobulins, hyperimmune products, and antitoxins. ** Blood and blood products activities are managed through the Office of Blood Research and Review ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Rheumatology
Rheumatology () is a branch of medicine devoted to the diagnosis and management of disorders whose common feature is inflammation in the bones, muscles, joints, and internal organs. Rheumatology covers more than 100 different complex diseases, collectively known as rheumatic diseases, which includes many forms of arthritis as well as lupus and Sjögren syndrome, Sjögren's syndrome. Physician, Doctors who have undergone formal training in rheumatology are called rheumatologists. Many of these diseases are now known to be disorders of the immune system, and rheumatology has significant overlap with immunology, the branch of medicine that studies the immune system. Rheumatologist A rheumatologist is a physician who specializes in the field of medical sub-specialty called rheumatology. A rheumatologist holds a board certification after specialized training. In the United States, training in this field requires four years of undergraduate school, four years of medical school, a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
