A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in ...

Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug development but suggest ...

Some of the most widely used biologic medicines in oncology have patents about to expire, opening the market to noninnovative versions of these drugs. There are already many examples of price ...

Survival extrapolation plays a pivotal role in cost-effectiveness analysis by extending observed clinical trial data to estimate long-term patient outcomes. Given that the follow‐up periods of trials ...