New FDA Guidances Aim to Reduce Number of Review Cycles

The FDA released two new guidances to help speed reviews of generic drugs and get the products to market more quickly.

“We want to reduce the number of cycles of review that generic applications undergo in order to make the generic approval process more efficient,” said FDA Commissioner Scott Gottlieb Gottlieb.

Gottlieb noted it typically takes about four review cycles for an ANDA to secure agency approval, frequently because the application does not include all the information needed and not because the product fails to meet approval standards.