FDA releases new guidance documents on when to submit an ANDA or 505(b)(2) application and on therapeutic equivalence evaluations

Last week, FDA issued two new guidance documents. The first was a revision to the draft guidance document describing when to submit an ANDA or 505(b)(2) application. It provides sponsors with greater clarity regarding when it is appropriate to use each of the abbreviated approval pathways available under the Federal Food, Drug, and Cosmetic Act.... By: Hogan Lovells Cadwalader