An FDA advisory committee narrowly voted against recommending an additional nerve block indication for Pacira’s Exparel, a local analgesic approved in 2011 for post-surgical pain management. Source: Drug Industry Daily
In Jan. 30 testimony before a House subcommittee, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s…
The FDA issued Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues. Source: Drug GMP Report
The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies. Source: Drug GMP Report
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Source: Drug GMP Report
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Source: The GMP Letter
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Source: The GMP…
Biomodeling Solutions drew an FDA warning letter after it failed to provide written responses to nonconformities identified in a Form 483. Source: The GMP Letter
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead…
Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Source: The GMP…