We have a new white paper for innovator companies that market complex drugs: "Innovator Company Advocacy for Heightened ANDA Approval Standards – Complex Drugs," authored by Lance L. Shea, M.S., J.D. and Lorin K. Johnson, Ph.D.
Our evidence-driven strategy discussed in the paper has improved the rigor of ANDA approval standards by obtaining two major revisions to the FDA’s draft guidance for generics of a client’s complex blockbuster drug.
Download the white paper here to stay ahead in the generic drug landscape.