Author: United StatesPublisher:
ISBN:
Category : Dietary supplements
Languages : en
Pages : 10
Book Description
An Act to Amend the Federal Food, Drug, and Cosmetic Act to Authorize Human Drug Application, Prescription Drug Establishment, and Prescription Drug Product Fees and for Other Purposes
Author: United StatesPublisher:
ISBN:
Category : Dietary supplements
Languages : en
Pages : 10
Book Description
Legislative History
Author: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (Us Food and Drug Administration Regulation) (Fda) (2018 Edition)
Author: The Law The Law LibraryPublisher: Createspace Independent Publishing Platform
ISBN: 9781727546538
Category :
Languages : en
Pages : 120
Book Description
Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine. This book contains: - The complete text of the Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section
Federal Regulation of Methadone Treatment
Author: Committee on Federal Regulation of Methadone TreatmentPublisher: National Academies Press
ISBN: 0309598621
Category : Medical
Languages : en
Pages : 251
Book Description
For nearly three decades, methadone hydrochloride has been the primary means of treating opiate addiction. Today, about 115,000 people receive such treatment, and thousands more have benefited from it in the past. Even though methadone's effectiveness has been well established, its use remains controversial, a fact reflected by the extensive regulation of its manufacturing, labeling, distribution, and use. The Food and Drug Administration regulates the safety and effectiveness of methadone, as it does for all drugs, and the Drug Enforcement Administration regulates it as a controlled substance. However, methadone is also subjected to a unique additional tier of regulation that prescribes how and under what circumstances it may be used to treat opiate addiction. Federal Regulation of Methadone Treatment examines current Department of Health and Human Services standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. The book includes an evaluation of the effect of federal regulations on the provision of methadone treatment services and an exploration of options for modifying the regulations to allow optimal clinical practice. The volume also includes an assessment of alternatives to the existing regulations.
Food and Drug Administration Advisory Committees
Author: Institute of MedicinePublisher: National Academies Press
ISBN: 0309048370
Category : Medical
Languages : en
Pages : 239
Book Description
Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
An Act to Amend the Federal Food, Drug, and Cosmetic Act to Revise and Extend the User-Fee Programs for Prescription Drugs and for Medical Devices, to Enhance the Postmarket Authorities of the Food and Drug Administration with Respect to the Safety of Drugs, and for Other Purposes
Author: United StatesA Legislative History of the Federal Food, Drug, and Cosmetic Act and Its Amendments
Author: United StatesPublisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 760
Book Description
Federal Food, Drug, and Cosmetic Act, as Amended and General Regulations for Its Enforcement, Title 21, Part 1
Author: United States. Department of Health, Education, and WelfarePublisher:
ISBN:
Category : Cosmetics
Languages : en
Pages : 88
Book Description
Federal Food, Drug, and Cosmetic Act, as Amended
Author: United StatesPublisher: Department of Health and Human Services Public Health Service Food and Drug Administration
ISBN:
Category : Cosmetics
Languages : en
Pages : 232
Book Description
Cover title: Federal Food, Drug, and Cosmetic Act, as amended.
Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and MedicinePublisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
Book Description
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.