Download or read book Oversight the Food and Drug Administration s Process for Approving New Drugs written by United States. Congress. House. Committee on Education and Labor. Subcommittee on Postsecondary Education and published by . This book was released on 1979 with total page 1299 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Oversight the Food and Drug Administration s Process for Approving New Drugs written by United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology and published by . This book was released on 1979 with total page 1324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food and Drug Administration Oversight written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1991 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book The Food and Drug Administration s Process for Approving New Drugs written by United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology and published by . This book was released on 1979 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA s Generic Drug Approval Process written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 1989 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Food and Drug Administration s Process for Approving New Drugs written by United States. Congress. House. Committee on Science and Technology. Subcommittee on Science, Research, and Technology and published by . This book was released on 1980 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book How FDA Approves Drugs and Regulates Their Safety and Effectiveness written by Susan Thaul and published by CreateSpace. This book was released on 2012-07-03 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Update: On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul. CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul. CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson. CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since September 1, 2011.) The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers' applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA's responsibilities regarding drug approval and regulation. The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review. Once a drug is on the U.S. market (following FDA approval of the NDA), FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and directto- consumer advertising, all topics in which Congress has traditionally been interested. FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs.~
Download or read book Food and Drug Administration written by Marcia Crosse and published by DIANE Publishing. This book was released on 2009-02 with total page 55 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Sept. 2000, the FDA approved the drug Mifeprex for use in terminating early term pregnancy. FDA approved the drug under a provision of its Subpart H regulations, allowing it to restrict the drug¿s distribution to assure its safe use. Critics argued that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. This report: (1) describes FDA¿s approval of Mifeprex, including the evidence considered and the restrictions placed on its distribution; (3) compares the Mifeprex approval process to the approval processes for other Subpart H restricted drugs; and (3) compares FDA¿s post-market oversight of Mifeprex to its oversight of other Subpart H restricted drugs. Illustrations.
Download or read book New Drug Approval written by Marcia Crosse and published by DIANE Publishing. This book was released on 2010-08 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: Before approving a drug, the FDA assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint (SE) -- a laboratory measure, such as blood pressure -- instead of more direct clinical evidence, like preventing strokes. After approval, FDA requires a drug sponsor to further study the drug. There have been concerns about FDA's reliance on SE and its oversight of post-marketing studies (PS). This report provides info. on: (1) all drug applications approved based on SE in FDA's accelerated approval process; (2) a subset of applications for potentially innovative drugs approved based on SE under FDA's traditional process; and (3) FDA's oversight of PS. Illustrations.
Download or read book The Need for FDA Regulatory Reform to Protect the Health and Safety of Americans written by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on National Economic Growth, Natural Resources, and Regulatory Affairs and published by . This book was released on 1996 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Regulation Reform oversight New drug approval process written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment and published by . This book was released on 1980 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book New Drug Approval written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-09-20 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: Before approving a drug, the Food and Drug Administration (FDA) assesses a drug's effectiveness. This assessment may be based on evidence showing that a drug has a positive impact on a surrogate endpoint-a laboratory measure, such as blood pressure-instead of more direct clinical evidence, like preventing strokes. After approval, FDA often requires or requests a drug sponsor to further study the drug. Concerns have been raised about FDA's reliance on surrogate endpoints and its oversight of postmarketing studies. This report provides information on (1) all drug applications approved based on surrogate endpoints in FDA's accelerated approval process, (2) a subset of applications for potentially innovative drugs approved based on surrogate endpoints under FDA's traditional process, and (3) FDA's oversight of postmarketing studies. GAO identified drugs approved based on surrogate endpoints, obtained the status of related postmarketing studies, and reviewed FDA's oversight of a sample of 35 studies it required under its accelerated approval process, selected to include studies which were at varying levels of completion.
Download or read book Council on Competitiveness and FDA Plans to Alter the Drug Approval Process at FDA written by United States. Congress. House. Committee on Government Operations. Human Resources and Intergovernmental Relations Subcommittee and published by . This book was released on 1993 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book How FDA Approves Drugs and Regulates Their Safety and Effectiveness written by Congressional Service and published by Createspace Independent Publishing Platform. This book was released on 2018-06-02 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases. In the preapproval (premarket) phase, FDA reviews manufacturers' applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. Once a drug is on the market, FDA continues its oversight of drug safety and effectiveness. That postapproval (postmarket) phase lasts as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress and the President have incrementally refined and expanded FDA's responsibilities regarding drug approval and regulation. The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. It carries out those tests, called clinical trials, sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). At that point, FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identity, strength, quality, and purity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements for each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track designation, breakthrough therapy designation, and priority review. Once FDA has approved an NDA, the drug may enter the U.S. market, but FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and direct-to-consumer advertising, all topics in which Congress has traditionally been interested. FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs. FDA's approval of an NDA includes the drug's labeling; the agency may require changes once a drug is on the market based on new information. It also prohibits manufacturer promotion of uses that are not specified in the labeling. The FFDCA requires that manufacturers report to FDA adverse events related to its drugs; clinicians and other members of the public may report adverse events to FDA. The agency's surveillance of drug-related problems, which had primarily focused on analyses of various adverse-event databases, is now expanding to more active uses of evolving computer technology and links to other public and private information sources. The FFDCA allows FDA to require a manufacturer to conduct postapproval studies of drugs. The law specifies when FDA must attach that requirement to the NDA approval and when FDA may issue the requirement after a drug is on the market. To manage exceptional risks of drugs, FDA may also require patient or clinician guides and restrictions on distribution. The agency publicly disseminates information about drug safety and effectiveness; and regulates the industry promotion of products to clinicians and the public.
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in
Download or read book FDA s Drug Approval Process written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2005 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
