Description
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This quarterly newsletter provides over 11 charts and graphs providing clear graphical data highlighting current regulatory trends for biologics and dietary supplements. An executive summary provides a synopsis of all data presented in the newsletter and significant changes in regulatory trends. Current Good Manufacturing Practices, Packaging and Clinical categories are successively drilled down to identify the top 8 citations for supplements. Key biologic and supplements regulatory subparts are identified through charts and graphs. Active links to all warning letters for the 2 yr time period reported are provided as well as links to FDA regulations for easy reference without the need to navigate the FDA website Among the many uses, newsletters are used to objectively evaluate risk, prioritize audit observations and corrective actions, prepare for internal audits and as training tools in addition to defining regulatory.
