The doctor told him to come back if his condition didn't improve - and it didn't
As FDA states in their guidance document on the Q-Submission program, Early interaction with FDA on planned non-clinical and clinical studies and careful consideration of FDAs feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices. While this is not meant to be a general pre-review of your submission, it is there to help you get answers to questions directly from FDAwhich will contribute to a smooth submission and, hopefully, approval
Still have questions on prohibited substances and methods
Periventricular leukomalacia Periventricular leukomalacia (PVL) is a diffuse damage of the cerebral white matter that extends beyond the periventricular regions found predominantly in preterm infants
And, if they've had a steroid injection in the past that made them feel better
Nonetheless, most patients usually apply up to 50% of the recommended layer of topical sunscreens on their skin, so products with higher SPF values (e.g., 50) are recommended for patients with pigmentary disorders [17]
