505b2 For Drugs
We require an expert to assist with 505b2 for a drug/device combination. We are repurposing an existing inhalation device coupled with a medical gas for home use. We plan to submit to the fda within 3-4 months and need help asap. We are looking for remote collaboration, thus location is of no importance. 505b2 has to be your core expertise. Referrals are also welcomed, thank you.