On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.  Read more... (228 words, 1 image, estimated 55 secs reading time)

The U.S. Food and Drug Administration on Jan. 24 issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement key aspects of the Drug Quality and Security Act and other provisions of the law relevant to compounders.  Read more... (238 words, estimated 57 secs reading time)

Five years after the New England Compounding Center (NECC) tragedy that brought to light safety problems stemming from the compounding of pharmaceuticals and other therapies, a white paper was released today reflecting the recommendations of major stakeholders for additional steps needed to improve patient safety relative to compounded medicines.  The paper was the outcropping of a milestone dialogue where top pharmacy, healthcare provider, hospital and patient organizations assessed progress made since the 2012 NECC tragedy and the subsequent enactment of the Drug Quality and Security Act by Congress.  Read more... (543 words, 1 image, estimated 2:10 mins reading time)

Law360, New York (January 3, 2018, 5:48 PM EST) — The U.S. Food and Drug Administration on Wednesday unveiled draft guidance for the pharmaceutical industry and an internal manual of policies and procedures that it says will streamline the approval process for generic drugs, in part by reducing the number of times an application must be reviewed.  Read more... (605 words, estimated 2:25 mins reading time)