The Government Accountability Office issues a report indicating that the Food and Drug Administration has met most of its performance goals when reviewing prescription drug applications, including new drug applications and biologic license applications, received from fiscal year (FY) 2000 through FY 2010.
The U.S. Patent and Trademark Office requests comments on whether the current framework used to keep patent applications involving U.S. security interests secret should be extended to establish a similar screening program for patent applications disclosing subject matter deemed to be detrimental to national economic security. Also solicited are comments on the criteria used when determining national security-related secrecy orders. Comments are requested by June 19, 2012.
The Food and Drug Administration (FDA) publishes a final rule to amend regulations on the disqualification of clinical investigators. Under the changes, when the food and drug commissioner “determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA.”
The Institute of Medicine releases a report titled “Ethical and Scientific Issues in Studying the Safety of Approved Drugs.” It concludes that “FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle.”