Newsletter - July 21, 2022
FDA Now Accepts Medical Device Applications Electronically
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...Read More
How to Create FDA Acceptable IFU: New Guidance
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...Read More
FDA Now Accepts Medical Device Applications Electronically
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...Read More
How to Create FDA Acceptable IFU: New Guidance
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...Read More
