ARTICLES BY PETER H. CALCOTT
FDA Finds Drug Shortages Are Mostly Caused By Quality Issues6/6/2022
New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.
Measuring The Impact Of Recent Regulatory Guidances On Pharma Quality Systems4/3/2017
This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations.
Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances2/15/2017
Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements.