US FDA to require paediatric information in submissions
This article was originally published in RAJ Devices
A new rule issued by the US Food and Drug Administration will make it mandatory for medical device manufacturers seeking premarket approval of their products to provide “readily available” information on paediatric patients who suffer from the disease or condition that the device is intended to treat/diagnose/cure, even if the device is intended for adult use1.
You may also be interested in...
Swissmedic will scale back its review procedure for certain anti-infectives if the indications for which approval is being sought are identical to those approved in the EU or the US.
Based on the operational experience gained using the new international standard for reporting suspected adverse reactions in EudraVigilance, the EU has decided to set a date for its mandatory use.
The UK’s Health Research Authority has agreed in principle to implement a new policy that aims to drive a lasting change in clinical trial transparency. Not everyone is convinced.