FDA Offers Updated Form for Field Alert Reports
By Michael Mezher -
Published 16 June 2017
The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.
Categories: News, US, FDA, Generic drugs, Prescription drugs, Postmarket surveillance
Tags: FAR, Field Alert Reports
FDA Warns B. Braun Medical’s California Plant for Repeat Violations
By Zachary Brennan -
Published 31 May 2017
The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015.
Categories: News, US, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy
Tags: B. Braun Medical, FDA warning letters, field alert reports, leaking IV bags