Related Research Articles
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
An approved drug is a medicinal preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is usually specific by country, unless specified otherwise.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), 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-emitting electronic devices, tobacco products, and veterinary medicine products which may have potentially harmful side effects for the consumer.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and pharmaceutical development markets.
Regulatory science is the scientific and technical foundations upon which regulations are based in various industries – particularly those involving health or safety. Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work safety.
Lurdes Yoshiko Tani Inoue is a Brazilian-born statistician of Japanese descent, who specializes in Bayesian inference. She works as a professor of biostatistics in the University of Washington School of Public Health.
Janet Woodcock 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.
Jodi Ann Lapidus is a professor of biostatistics and director of biostatics education at Oregon Health & Science University (OHSU).
Sharon-Lise Teresa Normand is a Canadian biostatistician whose research centers on the evaluation of the quality of care provided by physicians and hospitals, and on the health outcomes for medical devices and medical procedures. She is a professor in the Department of Health Care Policy at the Harvard Medical School and in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health.
Lisa Morrissey LaVange is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill where she directs the department’s Collaborative Studies Coordinating Center (CSCC), overseeing faculty, staff, and students involved in large-scale clinical trials and epidemiological studies coordinated by the center. She returned to her alma mater in 2018 after serving as the director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Her career also includes 16 years in non-profit research and 10 years in the pharmaceutical industry. She served as the 2007 president of the Eastern North American Region (ENAR) of the International Biometric Society (IBS), and as the 2018 American Statistical Association (ASA) president.
Dionne L. Price is an American statistician who works as a division director in the Office of Biostatistics of the Center for Drug Evaluation and Research, in the US Food and Drug Administration. Her division provides statistical advice "used in the regulation of anti-infective, anti-viral, ophthalmology, and transplant drug products".
Susan S. Ellenberg is an American statistician specializing in the design of clinical trials and in the safety of medical products. She is a professor of biostatistics, medical ethics and health policy in the Perelman School of Medicine at the University of Pennsylvania. She was the 1993 president of the Society for Clinical Trials and the 1999 President of the Eastern North American Region of the International Biometric Society.
Georgia "Gina" D. Tourassi is the Director of the Oak Ridge National Laboratory health data sciences institute and adjunct Professor of radiology at Duke University. She works on biomedical informatics, computer-aided diagnosis and artificial intelligence (AI) in health care.
Richard Eugene Barlow is an American mathematician and mathematical statistician, who is considered with Frank Proschan as the founder of modern reliability theory. He was a professor at the University of California, Berkeley from 1963 until his retirement in 1999.
Peter Marks is an American hematologist oncologist serving as the director of the Center for Biologics Evaluation and Research within the Food and Drug Administration. He was appointed to the position in 2016 after previously serving as deputy director. He has two children a daughter and a son. Dr. Marks resides in Washington, D.C. with his wife.
In an adaptive design of a clinical trial, the parameters and conduct of the trial for a candidate drug or vaccine may be changed based on an interim analysis. Adaptive design typically involves advanced statistics to interpret a clinical trial endpoint. This is in contrast to traditional single-arm clinical trials or randomized clinical trials (RCTs) that are static in their protocol and do not modify any parameters until the trial is completed. The adaptation process takes place at certain points in the trial, prescribed in the trial protocol. Importantly, this trial protocol is set before the trial begins with the adaptation schedule and processes specified. Adaptions may include modifications to: dosage, sample size, drug undergoing trial, patient selection criteria and/or "cocktail" mix. The PANDA provides not only a summary of different adaptive designs, but also comprehensive information on adaptive design planning, conduct, analysis and reporting.
Estelle Russek-Cohen is an American biostatistician and expert on biometrics. Formerly a professor at the University of Maryland, College Park and division director in the Center for Biologics Evaluation and Research or the Food and Drug Administration, she has retired to become a statistical consultant.
Sue-Jane Wang is a biostatistician at the United States Food and Drug Administration (FDA), where she works as the Biostatistics Lead and as the liaison from the Office of Biostatistics to the FDA Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. She is also deputy division director for biometrics in the Office of Biostatistics.
References
- ↑ "Telba Irony, PhD", Speaker biography, 37th Annual Meeting of the Society for Medical Decision Making, 2015, retrieved 17 November 2017
- ↑ "Telba Irony, FDA", Speaker biography, DIA 2017 Annual Meeting, 2017, retrieved 17 November 2017
- 1 2 3 Author profile from Irony, T.Z.; Barlow, R.E. (March 1993), "Curiosities in choosing system components: a Bayes analysis", IEEE Transactions on Reliability, 42 (1): 128–131, doi:10.1109/24.210283
- ↑ "Modeling, Information Extraction and Decision Making a Bayesian Approach to Some Engineering Problems", Hathitrust Digital Library, Catalog entry, 1989, retrieved 17 November 2017
- ↑ ASA Fellows list, American Statistical Association, retrieved 15 November 2017
- ↑ Excellence in Analytical Science 2009-Present, Food and Drug Administration, retrieved 22 November 2017
| International | |
|---|---|
| National | |
