FDA Manual To Address Pediatric Labeling Extrapolation From Adults
This article was originally published in The Tan Sheet
FDA's Office of Pediatric Therapeutics expects to develop by 2012 a manual to guide agency staff on the use of extrapolation when assessing pediatric products and their development programs
You may also be interested in...
The Institute for Safe Medication Practices calls for FDA to make a draft guidance on dosage delivery devices for liquid OTCs more restrictive to prevent consumer misdosing via standardized devices
The FDA Commissioner says the realignment of four deputy-level offices in the Office of the Commissioner will streamline "common activities" and strengthen science and food safety
An FDA advisory panel decided in split votes Oct. 19 to recommend immediately that all OTC cough/cold medicines should not be used for 2-to 5-year-old children but are safe for 6- to 12-year-olds