The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA...

Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.   Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...

BACKGROUND The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and no...

Shortages of pharmaceutical drugs pose a serious and growing threat to public health. Although the number of drugs in shortage in the United States in any given year is very small, the number of prescription drug shortages in the country nearly tripled between 2005 and 2010. Drug shortages are becoming more severe as well as more frequent. The affected medicines include cancer treatments, anest...

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about th...

indications for linezolid use are nosocomial or community-acquired pneumonia and skin infections or soft tissue infection caused by gram-positive microorganisms, but new recommendations may emerge. it is important to balance benefits with risks because severe adverse events have been described in patients taking linezolid treatment. accordingly, we evaluated the suitability of linezolid prescri...

background: as a major responsibility, health authorities must control rational prescription of drugs (rud). a way to analyze the regional status of drug prescription is the who’s recommended indices. the purpose of the study was to determine the status of drug prescriptions in pharmacies of healthcare centers under the authority of tehran university of medical sciences based on the who indices...