Regulatory Authority Actions

The management board of the European Medicines Agency (EMA) has endorsed the agency?s work programme and budget for 2013, which includes a budget of EUR231.6 million, a slight increase over 2012.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

USP revises labeling requirements for Heparin.

Will the next US President support the backbone of our industry?

The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimising the use of available expertise.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

The European Medicines Agency has launched a public consultation concerning its inventory of paediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

Import controls and risk strategies aim to promote quality and spur new drug development.

FDA Updates List of Warning Letters

How to handle and respond to a consent decree.

Has the long-awaited guidance answered all of the industry's questions?

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

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.