In a Warning Letter, FDA cited ?significant violations? of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out-of-specification batches, failure to clean and maintain equipment, and failure to ensure drugs? identity, strength, quality, and purity.
Rising imports, overseas production spur collaboration and realignment of enforcement activities.
Follow-on versions of complex biologics require extensive expertise.
The US Food and Drug Administration has designated XOMA 052, an antibody to interleukin-1 beta manufactured by XOMA, Ltd. (Berkley, CA), an orphan drug for the treatment of Behcet's disease.
Regulatory relief requires that regulators trust companies to know what they are doing, and to do it-consistently.
International outsourcing and rising theft spur regulatory action and manufacturer oversight.
The FDA is expanding postmarketing safety requirements, despite limited resources to manage these added responsibilities.
The new Sentinel system aims to expand access to data on medical product safety and patient effects.
One might look at QbD's plodding growth and conclude that it is never going to make it to graduation.
Do we really have to choose between saving money and saving time?
The FDA and Genzyme have notified healthcare professionals about the potential for foreign particle contamination of several Genzyme products: Cerezyme, Fabrazyme, Myozyme, and Thyrogen, which are supplied as lyophilized powders requiring reconstitution before administration; and Aldurazyme, which is supplied as a liquid solution. The foreign particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process, and could potentially cause serious adverse events in patients.
The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.
Stiffer enforcement of quality standards aims to restore public confidence in agency actions.
The introduction of two rival bills has intensified the long-simmering debate on biosimilars regulation in the US.
The truth is, we should have been afraid of H1N1, because the threat of a flu pandemic is real.
Agency officials promise swift action against violators of drug safety and quality regulations.
Importing foreign drugs is not the best way to increase access to medicine. The risks are too high, and it burdens the over-stretched FDA unfairly.
Avoiding healthcare reform is not the best option for the pharmaceutical industry.
How change plays out will depend not only on the new Whitehouse, but on pharma leaders' ability to adapt to changing times.
The FDA's QbD pilot program is supporting good manufacturing on a global basis.
The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.
The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information.
The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.
The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight.
More informed submissions may lead to regulatory flexibility for postapproval changes.
