FDA recently announced critically important information for all generic drug manufacturers which will require generic drug manufacturers to develop and implement safety-related changes to their labeling. If/when implemented, generic companies will have a paradigmatic shift in their role related to safety surveillance and labeling updates. Prior to this new rule generic companies could only change…
A recent study found that 78% of generic drug labels are inconsistent with the labeling of the reference listed drug (Duke et. Al 2012). While most of the differences were relatively minor, nearly one in ten were off by more than ten side effects. The researchers reviewed 9,105 labels representing over 1,500 drugs on DailyMed,…
Recently, representatives from PDG attended the second meeting of the Central Florida chapter of RAPS. Featured was a presentation by Leo J Lagrotte, Consumer Safety Officer, Food and Drug Administration (FDA), FLA-DO/TMP-RP entitled “FDA Perspective on Advertising and Promotional Compliance and Social Media”. Mr. Lagrotte’s patient and thorough explanation of topics such as solicited vs.…
The Food and Drug Administration (FDA) announced a public workshop entitled “Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.” The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the…