Results 1 to 10 of about 524,053 (116)
The United States Food and Drug Administration and Prescription Drug Promotion [PDF]
Journal of Innovations in Cardiac Rhythm Management, 2019 The impact of prescription drug promotion on health-care professionals (HCPs) is significant. Pharmaceutical industry spending on promotion to HCPs greatly outpaces spending on direct-to-consumer promotion. According to Syneos Health™ PromotionalAnswers, in 2017, the pharmaceutical industry spent more than $24 billion on drug promotion, with more than $
Kalola, Ankur S., Dean, Robert
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Unapproved drugs in the united states and the food and drug administration [PDF]
Advances in Therapy, 2011 Despite more than a century of evolving federal legislation, there remain many unapproved drugs on the United States (US) market. This article reviews the history of drug approval in the US, beginning with the landmark Pure Food and Drug Act of 1906, through to the development of the US Food and Drug Administration (FDA).
Nasr, Alexander +2 more
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Inhaled Insulin: Intrapulmonary or Intranasal? [PDF]
, 2012 Initial attempts delivered the insulin hormone intramuscularly, intravenously, and eventually subcutaneously. Other routes of administration of the drug were explored.
Danish Ahmed +3 more
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Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]
, 2013 This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
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Is Simpler Always Better? Consumer Evaluations of Front-of-Package Nutrition Symbols [PDF]
, 2011 Consumers of packaged goods products in the United States recently have faced an onslaught of front-of-package (FOP) nutrition symbols and icons, including the controversial “Smart Choices” single summary indicator.
Andrews, J. Craig +2 more
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Decisions by regulatory agencies: are they evidence-based? [PDF]
, 2007 Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based.
Curt D Furberg
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A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms [PDF]
, 2012 Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases.
Prohotsky, Daniel, Zhao, Fang
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Food and drug administration approval process for dermatology drugs in the United States
Journal of Dermatological Treatment, 2018 The purpose of this review is to elucidate the steps involved in the FDA's approval of new dermatology drugs.To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three ...
Emily Boozalis +2 more
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The ethics and politics of compulsory HPV vaccination [PDF]
, 2006 On September 12, 2006, 3 months after the Food and Drug Administration licensed a vaccine against human papillomavirus (HPV), Michigan lawmakers became the first in the United States to propose that vaccination be compulsory for girls entering sixth ...
Colgrove, James K.
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WHEELCHAIR SAFETY???ADVERSE REPORTS TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION
American Journal of Physical Medicine & Rehabilitation, 1994 Evidence has been accumulating that injuries related to wheelchair use are common and sometimes serious. The object of this study was to evaluate the databases of the Food and Drug Administration (FDA) for insights to the nature and causes of such problems. We analyzed 651 records that were received by the FDA between 1975 and 1993.
R L, Kirby, S A, Ackroyd-Stolarz
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