Drug Labels May Inadequately Address Efficacy and Risk

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...

New Center of Excellence for Regulatory Science proposed by FDA

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...

Australian TGA adopts ICH M3(R2) Nonclinical Guidance

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...

New FDA Transparency Impacts Drug Safety

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...