Assignment task: Please help me find a list of medications approved in the last 5 years for treating asthma. The medications should not be biosimilars and should have sufficient information for use in my assignment.
As you begin to work on your upcoming assignments, I wanted to especially comment on your Week 3 assignment (Pre-IND Meeting Request and Package). Be advised that this assignment is to contain two separate documents (they can be combined in the same file, but clear distinction must be made). Imagine you are submitting these documents to FDA. You would first submit your meeting request--after FDA grants your meeting request you would follow up with submitting your meeting package. Be sure to review the FDA guidance regarding meeting requests and packages. There is very clear formatting/content to follow for each document and your work will be graded accordingly.
This same process will apply to your Pre-NDA Meeting Request and Package assignment. Need Assignment Help?