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United States Food and Drug Administration seeks global regulatory regime. [PDF]

open access: goldCMAJ, 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

The United States Food and Drug Administration and Prescription Drug Promotion. [PDF]

open access: yesJ 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 Healthâ„¢ PromotionalAnswers, in 2017, the pharmaceutical industry spent more than $24 billion on drug promotion, with more than $
Kalola AS, Dean R.
europepmc   +4 more sources

United States Food and Drug Administration Product Label Changes. [PDF]

open access: greenJ 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   +5 more sources

An introspection of quality of novel drug approvals by United States Food and Drug Administration

open access: diamondInternational 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 ...
Rekha Mehani, Ajay Kumar Shukla
openalex   +3 more sources

Methanol poisonings from contaminated hand sanitizers identified by the United States Food and Drug Administration. [PDF]

open access: greenClin Toxicol (Phila), 2023
Konkel K   +7 more
europepmc   +3 more sources

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