In early April, Contract Pharma published an article addressing what you need to know prior to submission. The author, Michelle Ryder, Principal Consultant in the Regulatory Practice of Lachman Consultants, explains “there are a few avenues FDA has opened to get to your destination of knowing what you need to know prior to submission.”
How many conversations, or shall we call them “debates”, have you had within your organization trying to decipher exactly what FDA means in a guidance document, presentation, or even in a product-specific information request or a Complete Response Letter (CRL)?
