The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003.

The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

On 6-7 September 2010 the European Medicines Agency (EMA) held an international workshop with a broad cross section of stakeholders from around the world to discuss a way forward for a global framework of clinical trials that has at its heart the protection of the rights, safety and wellbeing of patients participating in clinical trials anywhere in the world.

The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland.

The U.S. Food and Drug Administration proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products.

The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile.