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Author :
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.3/5 (91 download)
Download or read book Approved Prescription Drug Products written by and published by . This book was released on 1980 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanied by supplements.
Author :
Publisher :
ISBN 13 :
Total Pages : 144 pages
Book Rating : 4.3/5 (91 download)
Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Food and Drug Administration
Publisher : DrugPatentWatch.com
ISBN 13 : 1934899828
Total Pages : pages
Book Rating : 4.9/5 (348 download)
Download or read book Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 32nd Edition (2012) written by Food and Drug Administration and published by DrugPatentWatch.com. This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Orange Book 32nd Edition - 2012 (Approved Drug Products With Therapeutic Equivalence Evaluations)
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)
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.
Author :
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ISBN 13 :
Total Pages : 336 pages
Book Rating : 4.3/5 ( download)
Download or read book Approved Prescription Drug Products with Therapeutic Equivalence Evaluations written by and published by . This book was released on with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Donald Light
Publisher : Columbia University Press
ISBN 13 : 0231146922
Total Pages : 179 pages
Book Rating : 4.2/5 (311 download)
Download or read book The Risks of Prescription Drugs written by Donald Light and published by Columbia University Press. This book was released on 2010 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Raises key questions about topics in the pharmaceutical industry, including how the risks of side effects are weighed, if privatization of that risk is prudent, and the high prices for drugs.
Author : DIANE Publishing Company
Publisher : DIANE Publishing
ISBN 13 : 9780788104053
Total Pages : 740 pages
Book Rating : 4.1/5 (4 download)
Download or read book Approved Drug Products with Therapeutic Evaluations written by DIANE Publishing Company and published by DIANE Publishing. This book was released on 1995-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Composed of 4 parts: approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Sect. 505 of the Act; & products that have never been marketed, have been discontinued from marketing, or that have had their approvals withdrawn for other than safety or efficacy reasons.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309468086
Total Pages : 235 pages
Book Rating : 4.3/5 (94 download)
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author : Thomson
Publisher : Wiley-Blackwell
ISBN 13 : 9781563636714
Total Pages : 0 pages
Book Rating : 4.6/5 (367 download)
Download or read book Red Book written by Thomson and published by Wiley-Blackwell. This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new "2008 Red Book" not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics.
Author : Barry Leonard
Publisher :
ISBN 13 : 9781422302071
Total Pages : 1014 pages
Book Rating : 4.3/5 (2 download)
Download or read book Approved Drug Products with Therapeutic Equivalence Evaluations written by Barry Leonard and published by . This book was released on 2005-11 with total page 1014 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multi-source prescription drug products.
Author : Joanne S. Hawana
Publisher :
ISBN 13 :
Total Pages : 185 pages
Book Rating : 4.:/5 (112 download)
Download or read book Promotion of FDA-regulated Medical Products written by Joanne S. Hawana and published by . This book was released on 2018 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promotion of FDA-Regulated Medical Products is the update of the 2013 publication, FDA requirements for prescription drug promotion, by John Driscoll.
Author : United States. General Accounting Office
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (7 download)
Download or read book Drug Safety written by United States. General Accounting Office and published by . This book was released on 2001 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Center for Drug Evaluation and Research (U.S.)
Publisher :
ISBN 13 :
Total Pages : 64 pages
Book Rating : 4.3/5 (243 download)
Download or read book An Introduction to FDA Drug Regulation written by Center for Drug Evaluation and Research (U.S.) and published by . This book was released on 1990 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.3/5 (121 download)
Download or read book Generic Animal Drugs 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 1987 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Donald O. Beers
Publisher : Wolters Kluwer
ISBN 13 : 1454836091
Total Pages : 2154 pages
Book Rating : 4.4/5 (548 download)
Download or read book Generic and Innovator Drugs written by Donald O. Beers and published by Wolters Kluwer. This book was released on 2013-05-22 with total page 2154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
Author : DIANE Publishing Company
Publisher :
ISBN 13 : 9780788146275
Total Pages : 753 pages
Book Rating : 4.1/5 (462 download)
Download or read book Approved Drug Products with Therapeutic Equivalence Evaluations written by DIANE Publishing Company and published by . This book was released on 1997-07 with total page 753 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309101476
Total Pages : 481 pages
Book Rating : 4.3/5 (91 download)
Download or read book Preventing Medication Errors written by Institute of Medicine and published by National Academies Press. This book was released on 2007-01-11 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation's quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the seriesâ€"To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)â€"this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.
