A source of 505(b)(2) opportunities comes from products that have been discontinued. One of the first things that must be done is to determine why it was discontinued - by law, the product must not have been discontinued for reasons of safety or efficacy. You can check to see if the FDA has made this [...]
Archive for September 14th, 2007
Why does Camargo recommend not to use a CMO’s testing lab for development? CMO labs are tailored for commercial production, characterized by many SOP’s and schedules. During early drug development we need answers quickly, sometimes even approximate answers. We’re not bound at this stage by GMPs. We have several outside labs, so we can select one that is [...]
You’re choosing excipients and determining amounts, so you go to the IAG (Inactive Ingredient Guide) look up the approved amounts and you’re good to go. Right?
Maybe not… You need to consider EXPOSURE. Exposure is amount over time. Look at the IAG and determine what products have this excipient/inactive ingredient and compute the potential exposure and [...]
