FDA approval does not mean that a drug works well; it means only that the Agency deemed its benefits to outweigh its harms. لعب بوكر Comparative efficacy data, other than to placebo, may be missing from the label. In 2006, the FDA revised the drug label design,...
FDA commissioner Dr. Margaret Hamburg launched a new initiative to innovate regulatory science so that it can keep pace with the evolution of biomedical research. New pilot and feasibility studies are proposed to investigate early drug safety and efficacy. In...
In the FDA’s effort to make both its decisions and clinical trial data more transparent to the public, Agency decisions have become more available for public debate. Sophisticated analyses (increasingly by third parties) of publically available data may present...
In February 2010 the FDA published “Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names” (Guidance), which describes in detail the FDA’s evaluation methodology for proposed proprietary drug names. By carefully...
Prior to drug approval, a potential new drug is usually subjected to the scrutiny of an expert advisory panel, selected by the FDA, who recommend whether or not the product should be marketed. These recommendations are non-binding. Industry analysts looked at...
As of 15 June 2010, the new Food and Drug Administration (FDA) Postmarketing Drug Safety Evaluation website was launched. The FDA posted postmarket safety evaluations for 26 drugs approved between September 2007 and January 2008 and is reviewing an additional 20 or...
