For pharmaceutical companies, is personalized medicine more of a threat than an opportunity? In addition to the development of new drugs, genetic information can also help target the use of current medications (e.g., Plavix). The use of genetic (or other)...
All medical products pose risks and postmarketing surveillance is critical to expanding the limited evidence base that exists when new drug products are approved. Through initiation of the Sentinel Initiative (May 2008), the Food and Drug Administration (FDA) is...
Ideally, every new drug would represent an unprecedented breakthrough and lead to the creation of a completely novel treatment. This, however, is not the reality of the pharmaceutical industry, or of any other development-based industry. Creating drugs based on...
FDA approval does not mean that a drug works well; it means only that the Agency deemed its benefits to outweigh its harms. Comparative efficacy data, other than to placebo, may be missing from the label. In 2006, the FDA revised the drug label design, adding a...
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...
The Australian TGA has adopted the EU Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3(R2)bb). The effective date was November 5, 2010. The purpose of this document is to...
