The U.S. Food and Drug Administration today released its “Strategic Plan for Regulatory Science,” calling for a sweeping modernization of the science used in developing and evaluating products critical to the nation’s health, economy, and security.
Category Archives: Drug Safety Information Podcasts
FDA proposes guidelines that clarify benefit-risk determinations for medical devices
For the first time, the U.S. Food and Drug Administration has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.
FDA seeks comment on proposed guidelines for high-quality clinical studies
The FDA today issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
FDA, state of Arkansas sign agreement to advance regulatory science
An agreement to establish a virtual Center of Excellence for Regulatory Science was signed today between the U.S. Food and Drug Administration’s National Center for Toxicological Research (NCTR) and the state of Arkansas.
FDA approves the first specific treatment for scorpion stings
The U.S. Food and Drug Administration today approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.
FDA reopens comment period on proposed ‘gluten-free’ food labeling rule
The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.
FDA, international counterparts report progress on drug inspection collaboration
FDA, international counterparts report progress on drug inspection collaboration
FDA to seek public comment on IOM recommendations
The FDA today announced that it will open a public docket to begin receiving public comments on the Institute of Medicine’s (IOM) report on the 510(k) program, the most common pathway to market for lower-risk medical devices.
Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe
The U.S. Food and Drug Administration (FDA) is warning U.S. consumers not to use the emergency birth control medicine labeled as Evital. These products may be counterfeit versions of the “morning after pill” and may not be safe or effective in preventing pregnancy.
FDA Center for Drug Evaluation and Research develops strategic science and research agenda
A U.S. Food and Drug Administration report from its Center for Drug Evaluation and Research (CDER), available today in the Federal Register, identifies the current regulatory science needs that will guide CDER’s strategic planning of internal research initiatives and contributions to the development of agency regulatory science efforts.