Results 1 to 10 of about 690,240 (260)
The United States Food and Drug Administration and Prescription Drug Promotion. [PDF]
J Innov Card Rhythm Manag, 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 AS, Dean R.
europepmc +5 more sources
An introspection of quality of novel drug approvals by United States Food and Drug Administration [PDF]
International Journal of Basic & Clinical Pharmacology, 2018 Background: United States Food and Drug Administration (FDA) is the fastest drug review agency in the world. FDA is responsible for protection of the public health by assuring that foods are safe, wholesome, sanitary and properly labelled. Approved Novel drugs are often innovative products that serve unmet medical needs or otherwise help to advance ...
Ajay Kumar Shukla, Rekha Mehani
openaire +4 more sources
United States Food and Drug Administration seeks global regulatory regime. [PDF]
CMAJ, 2011 The United States Food and Drug Administration (FDA) is proposing to develop and lead a more coordinated global approach to the inspection and monitoring of foods, drugs and medical devices. Globalization is forcing the development of a more coordinated international approach to regulation of ...
Walkinshaw E.
europepmc +4 more sources
United States Food and Drug Administration Product Label Changes. [PDF]
J Clin Aesthet Dermatol, 2016 Once a drug has been approved by the United States Food and Drug Administration and is on the market, the Food and Drug Administration communicates new safety information through product label changes. Most of these label changes occur after a spontaneous report to either the drug manufacturing companies or the Food and Drug Administration MedWatch ...
Kircik L +3 more
europepmc +3 more sources
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).
Matthew W. Davis +2 more
openaire +3 more sources
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
core +2 more sources
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.
core +1 more source
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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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
core +3 more sources
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.
Stacey A. Ackroyd-Stolarz, R. Lee Kirby
openaire +3 more sources