kim’s overview of food and drug administration (fda) regulatory actions from 2005 to 2014 is a comprehensive analysis of the us regulatory experience with online direct-to-consumer advertising (dtca) of prescription medicines. this experience is of relevance internationally as online dtca reaches the english-speaking public globally, despite the illegality of dtca in most countries. the most co...

OBJECTIVE Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the...

six months administration of bromocriptine mesylate significantly decreased glycated hemoglobin (hba1c), fasting blood sugar, postprandial blood sugar, and weight of 22 indian obese patients with type 2 diabetes mellitus with no serious adverse events. therefore, the novel mechanism of action, efficacy and acceptable safety profile makes this drug an attractive option for treatment of obese typ...

Objectives: To assess the extent to which teratogenic drugs are prescribed during pregnancy and to investigate. the feasibility of an alert system at the point of prescription, in order to improve drug safety during pregnancy. Methods: We establish a reference list of teratogenic drugs by merging lists of teratogenic drugs published in the literature, extract drug prescriptions to pregnant wome...

Many promising therapeutic agents are limited by their inability to reach the systemic circulation, due to the excellent barrier properties of biological membranes, such as the stratum corneum (SC) of the skin or the sclera/cornea of the eye and others. The outermost layer of the skin, the SC, is the principal barrier to topically-applied medications. The intact SC thus provides the main barrie...