Skip to content

CategoryPublication planning

Final rule clarifies and expands results reporting requirements of the FDA Amendments Act

It is a legal requirement for those responsible for certain applicable clinical trials of FDA-regulated products to register the studies on ClinicalTrials.gov and report results within a defined timeframe, as … Continue Reading Final rule clarifies and expands results reporting requirements of the FDA Amendments Act

Defining ghostwriting: ISMPP and GAPP respond to controversial BMJ article

The British Medical Journal (BMJ) recently published an article titled ‘Ghostwriting: the importance of definition and its place in contemporary drug marketing’. In the article, the author, Alastair Matheson, describes … Continue Reading Defining ghostwriting: ISMPP and GAPP respond to controversial BMJ article