Abstract
FDA to Create Drug Safety Board In February 2005, the Food and Drug Administration (FDA) announced that it will create a new independent Drug Safety Oversight Board (DSB) to oversee the management of drug safety issues within the Center for Drug Evaluation and Research (CDER). The FDA Commissioner will appoint individuals from the FDA and medical experts from other Health and Human Services agencies and government departments to the DSB, which also will consult with other medical experts and patient and consumer group representatives. Additionally, the FDA is proposing a new “Drug Watch” web page for emerging data and risk information, and anticipates an increased use of information sheets written for healthcare professionals and patients. Because of the potential concerns associated with disseminating emerging information prior to regulatory action, the agency has stated it will solicit public input. The FDA will issue draft guidance on procedures and criteria for identifying drugs and information for the Drug Watch web page.
Disciplines
Antitrust and Trade Regulation
Date of this Version
April 2005
Recommended Citation
Mark Heller, Hollie Baker, Robert Barry, James Burling, and Suyong Kim, "Pharma Bulletin - Spring 2005" (April 2005). Wilmer Cutler Pickering Hale and Dorr Antitrust Series. Working Paper 57.
https://law.bepress.com/wilmer/art57