The U.S. Food and Drug Administration asked manufacturers to add new warnings to labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. The warnings would alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications.

The U.S. Food and Drug Administration warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis.

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

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.