Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles by Patricia Van Arnum

The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.

The Critical Path Institute announced last week the formation of the Coalition Against Major Diseases, a formal consortium of pharmaceutical companies, research foundations, patient-advocacy groups, health organizations, and regulatory agencies, which will share information on clinical trials for treatments for neurodegenerative diseases.

The American Association for the Advancement of Science rolls out several initiatives to increase partnerships and communication on human rights between scientific groups and between scientific and human rights groups.

In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.

The biopharmaceutical company Genzyme (Cambridge, MA) provided an update on its manufacturing operations following the issuance of a draft consent decree by the FDA regarding the company?s Allston Landing, Massachusetts, manufacturing plant.