Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU Medical Device Regulation (EU MDR) submissions, but there is limited guidance on survey procedure ...

The US Food and Drug Administration (FDA) has issued draft guidance on developing cancer drugs intended for use in combination with other therapies. The guidance focuses on demonstrating each drug's ...

Most pivotal clinical trials supporting the accelerated approval of nononcology products reported surrogate measures as primary endpoints, according to a recent research letter published in JAMA.

PDG said selection of the Korean Pharmacopoeia was a consensus decision that @reflects the quality of the Korean Pharmacopoeia@s application and its alignment with the PDG@s mission to promote global ...