July 6, 2012 | Vol. 4 No. 27
Covidien’s January recall of a surgical staple product hasn’t ended the company’s troubles, as an FDA warning letter questioning Covidien’s handling of safety concerns makes clear.
The FDA should work with other regulatory bodies, especially the European Medicines Agency (EMA), to create a single marketing application that would be accepted by multiple regulators, drug industry insiders urge.
Drugmakers should apply a lifecycle approach to process validation — tying together data on product and process development, the commercial manufacturing process and maintenance and consistency of the process during routine commercial production, according to the European Medicines Agency (EMA).
Medtronic Spine received a Form 483 for various process control deviations at the conclusion of a Nov. 28, 2011, – Dec. 5, 2011, inspection at its Sunnyvale, Calif., plant.
Two days of public debate over the safety of metal-on-metal (MoM) implantable hip prostheses raised a host of questions, but few answers.
Companies manufacturing and distributing unapproved oxycodone products have 45 days to stop producing the pain meds and 90 days to cease shipping them or risk ramped up FDA enforcement.
The FDA is developing new methods and laboratory expertise to aid reviewers in identifying potential vulnerabilities and assessing risk mitigation measures for medical software.
Shertech Laboratories received a Form 483 after investigators found an array of procedural lapses that ultimately led the company to halt its first try at manufacturing prescription generics.
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