7.
FDA reviews application to determine if the drug’s
benefits outweigh its known risks. The review team includes experts in
medicine • pharmacology • chemistry •

biopharmaceutics
• statistics • microbiology (as
needed). FDA may ask for additional information, and may hold advisory
committee meeting to get outside expert advice.
8. FDA reviews information that will go in the
drug’s
labeling (instructions for, and information about, using the drug).
9. FDA
inspects the places where the drug will be made, and how it will
be made.

10. FDA
decides whether the drug can be approved, which would allow the
drug
to be sold in the U.S.
GPRC can support during development and post approval phases