Day: July 21, 2022

The Instructions For Use (IFU) provide critical information on how to use or administer a drug or biologic product for a patient or caregiver. FDA expects the IFU to be written in a simple non-technical language, in active voice, with size 10 or above font preferably Arial or Verdana, avoiding shading or highlights and many … Read more

While electronic submissions for drug and biologics applications have existed for more than a decade, medical device applications still get submitted as printed submissions and electronic copies that must be physically delivered to the FDA headquarters near Washington DC. Finally, this week, FDA started accepted truly electronic submissions for medical device applications and the process … Read more