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FDA Posts Draft Guidance on Requesting Nonbinding Feedback After Device Inspections
February 15, 2019 |FDA

The Food and Drug Administration posted a new draft guidance document on “nonbinding feedback” provided by the agency after inspections of device establishments. The draft guidance explains how device establishments may submit requests for nonbinding feedback to FDA on actions the company has proposed to take to address certain kinds of observations from FDA inspections. The document outlines a “standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests,” the agency said. Comments are due April 22.

FDA Issues First Warning Letter for Drug Supply Chain Law Violations
February 12, 2019 |FDA

The Food and Drug Administration recently issued its first warning letter for violations under the Drug Supply Chain Security Act, FDA Commissioner Scott Gottlieb said in a Feb. 12 statement. McKesson Corp., a U.S. distributor of pharmaceuticals, was cited for its failure to sufficiently respond to notifications from a pharmacy it supplied that there was illegitimate product in its supply chain -- opioid pills were missing from bottles that were distributed by McKesson -- and did not quarantine and investigate suspect products or maintain records of investigations of suspect product, Gottlieb said. “We’ll continue our efforts to help ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace medications -- including opioids -- as they move through the supply chain, and to respond to incidents involving illegitimate products in order to protect the public health,” Gottlieb said.