Day: September 29, 2022

Including children in clinical trials poses unique challenges and FDA’s latest guidance document on the topic acknowledges and highlights all the reasons why so few trials are done in pediatric subjects. The guidance confirms the conventional wisdom that trials in children must be adequately justified, properly designed to minimize risk to children, and avoided if … Read more

This week, FDA formally announced that it has stopped accepting Emergency Use Authorizations (EUAs) for most Covid diagnostic tests. While this should not come as a surprise to most, this announcement should settle this issue for anyone still hoping to submit an EUA for such tests. EUAs are an important tool for rapidly releasing unapproved … Read more