Frank Edward Young (September 1,1931 –November 24,2019) was an American physician who served as Commissioner of Food and Drugs from 1984 to 1989 [2] and later as a deputy assistant secretary in the United States Department of Health and Human Services. [3] In 2013 he joined Braeburn Pharmaceuticals as executive vice president,clinical and regulatory affairs. [4] In 2018,he became the executive vice president of clinical and regulatory affairs at TissueTech Inc. [5]
Young received an M.D. degree (cum laude) from the State University of New York Upstate Medical Center in Syracuse in 1956 and a Ph.D. in microbiology from Western Reserve University in Cleveland,Ohio,in 1962. [6]
Young completed his residency in pathology at the University Hospitals,Western Reserve University. He went on to become chairman of the Department of Microbiology and professor of microbiology,pathology and radiation biology and biophysics at the University of Rochester. Before his appointment as Commissioner of the Food and Drug Administration,he was dean of the School of Medicine and Dentistry and vice president for health affairs at the University of Rochester. [7]
Young was sworn in as Commissioner of the Food and Drug Administration by Secretary of Health and Human Services Margaret Heckler on August 2,1984. During his tenure,Young presided over several major agency events,including the Drug Price Competition and Patent Term Restoration Act (1984),passage of the Prescription Drug Marketing Act (1987),approval of the first drug to combat AIDS,zidovudine (AZT) (1987),development of the treatment use of Investigational New Drugs (IND) for the desperately ill,such as people with AIDS,cancer and heart disease (1988);managing the generic drug crisis (1989), [8] during which three officials of the Food and Drug Administration pleaded guilty to receiving bribes,and two manufacturers of generic drugs admitted to providing false data, [9] and the 1989 Chilean grape scare,where Chilean grapes were temporarily banned by the FDA because of a threat and the discovery of two cyanide-tainted grapes.
Young left the FDA in 1989 to become Deputy Assistant Secretary for Health,Science,and Environment under Health and Human Services Secretary Louis Wade Sullivan. Subsequently,Young served as director of both the Office of Emergency Preparedness and the National Disaster Medical System during the Clinton Administration,from 1993 until his retirement from federal service in 1996. [10]
In 2013,Young joined Braeburn Pharmaceuticals as executive vice president,clinical and regulatory affairs to contribute to the development of the new drug application (NDA) to FDA for evaluation of Braeburn’s Probuphine (buprenorphine) implant,which was approved on May 26,2016. [11] Probuphine is the first buprenorphine implant for the maintenance treatment of opioid dependence. [12]
Young has advised numerous pharmaceutical companies on regulatory issues and clinical development. He served as interim vice president for clinical and regulatory affairs of Bioventus Global and became an adjunct partner and partner at Essex Woodlands in 2002. He also co-founded the Cosmos Alliance and served as its chairman and chief executive officer. [13]
He served as the executive vice president of clinical and regulatory affairs at TissueTech Inc,where he was tasked to lead the company in its transition from a HCT/P regulated company into a biologics company through the pursuit of multiple NDAs for ultimate BLA approval.
Young contributed to more than 200 scientific publications in the fields of biotechnology and pathology and developed some of the earliest cloning enzymes,vectors,and vehicles. He is a member of the National Academy of Medicine. [14]
At the Department of Health and Human Services,Young received a Secretary’s Special Citation and the Inspector General’s Award for Outstanding Integrity. He also received the Surgeon General’s Exemplary Service Medal from the United States Public Health Service and the 2006 Distinguished Alumnus Award from SUNY Upstate Medical University. [15]
In 2015,Young was awarded the 2015 Distinguished Scientist Award by the American College of Toxicology for his outstanding contributions to toxicology and the improvement of public health. [16]
Young was the son of Frank E. and Erma F. Young. He served in the United States Navy in the Ready Reserve from 1956-1964 and retired in 1996 from the Commissioned Corps of the United States Public Health Service as a rear admiral after 12 years of Service. [17] He was married to the former Leanne Hutchinson from 1956 until her death in 2008. They had five children. [18] Young also served as a pastor in the Evangelical Presbyterian Church for approximately six years before retiring as pastor emeritus. [17]
He died of lymphoma on November 24,2019,in Wilmington,North Carolina at age 88. [19]
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.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages,cosmetics,pharmaceutical products,dietary supplements,and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality,from batch to batch,for their intended use.
Buprenorphine,sold under the brand name Subutex among others,is an opioid used to treat opioid use disorder,acute pain,and chronic pain. It can be used under the tongue (sublingual),in the cheek (buccal),by injection,as a skin patch (transdermal),or as an implant. For opioid use disorder,the patient must have moderate opioid withdrawal symptoms before buprenorphine can be administered under direct observation of a health-care provider.
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine,designed for use across Europe,Japan,the United States,and beyond.
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312. Similar procedures are followed in the European Union,Japan,and Canada due to regulatory harmonization efforts by the International Council for Harmonisation.
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group,dosage,or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways,although most studies of off-label use focus on prescription drugs.
Toxicogenomics is a subdiscipline of pharmacology that deals with the collection,interpretation,and storage of information about gene and protein activity within a particular cell or tissue of an organism in response to exposure to toxic substances. Toxicogenomics combines toxicology with genomics or other high-throughput molecular profiling technologies such as transcriptomics,proteomics and metabolomics. Toxicogenomics endeavors to elucidate the molecular mechanisms evolved in the expression of toxicity,and to derive molecular expression patterns that predict toxicity or the genetic susceptibility to it.
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 Peter Marks,M.D.,PhD. CBER is responsible for assuring the safety,purity,potency,and effectiveness of biologics and related products. 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).
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical,pharmaceutical,and scientific expertise to protect and advance public health and safety.
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 Center for Devices and Radiological Health (CDRH) is one of six product centers of the U.S. Food and Drug Administration (FDA),an agency that is part of the U.S. Department of Health and Human Services (HHS). CDRH is responsible for ensuring that patients and providers in the U.S. have timely and continued access to safe,effective,and high-quality medical devices and safe radiation-emitting products.
Critical Path Institute (C-Path) is a non-profit organization created to improve the drug development process;its consortia include more than 1,600 scientists from government regulatory and research agencies,academia,patient organizations,and bio-pharmaceutical companies.
The Reagan-Udall Foundation for the Food and Drug Administration is a private nonprofit (501c3) organization,created to support the mission of the U.S. Food and Drug Administration (FDA) to help equip FDA staff with the highest caliber,regulatory science and technology in order to enhance the safety and effectiveness of FDA regulated products. Although it was mandated by Congress in the Food and Drug Administration Amendments Act of 2007 to help support and promote FDA's regulatory science priorities,it is independent of the agency,with its own Board of Directors,staff and research agenda. The Reagan-Udall Foundation creates public–private partnerships to advance research in regulatory science,enhance medical decision making,and promote innovation. It also advances regulatory science through fellowships and other training programs,both for private scientists and for FDA staff.
The Food and Drug Administration is a federal agency of the United States,formed in 1930.
Brett P. Giroir is an American pediatrician. He was formerly the U.S. assistant secretary for health,a four-star admiral in the U.S. Public Health Service Commissioned Corps and an acting Food and Drug Administration commissioner.
Robert McKinnon Califf is an American cardiologist who currently serves as the 25th Commissioner of the Food and Drug Administration.
A botanical drug is defined in the United States Federal Food,Drug,and Cosmetic Act as a botanical product that is marketed as diagnosing,mitigating,treating,or curing a disease;a botanical product in turn,is a finished,labeled product that contains ingredients from plants. Chemicals that are purified from plants,like paclitaxel,and highly purified products of industrial fermentation,like biopharmaceuticals,are not considered to be botanical products.
Timothy R. Coté is an American doctor,expert of infectious and neoplastic disease,and a former director of the Office of Orphan Products Development (OOPD) at the Food and Drug Administration (FDA).
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions,recommendations,and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians,researchers,and professionals involved in designing,conducting,analyzing,and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States,the term "Guidances" is used,while in Europe,the term "Guidelines" is employed.
Janet Woodcock 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.