Letters from S M Burroughs: the birth of a worldwide pharmaceutical enterprise.

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

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...

The Need to Establish a Common Base Line for the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets

O-25: The Risk of Major Birth Defects in-ICSI and Normal Infants

Background: In the past 22 years, intracytoplasmic sperm injection (ICSI) on human oocytes become a successful method of treatment for most categories of infertility. But there are real concerns that possible malformations among ICSI infants are still not fully recognized. Despite the success of ICSI, the risk of major birth defects due to various parental factors or treatment may increase. We ...

The Need to Establish a Common Base Line for the Characteristics of Safety Withdrawal of Prescription Drugs from Worldwide Pharmaceutical Markets

Considering the Future of Pharmaceutical Promotions in Social Media; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding online direct-to-consumer promotions of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative ...