Complex products


MaPP Out – What Constitutes a Complex Generic Drug? FDA Explains

On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification.  A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they  utilize […]

Read More

New Complex Generics PSGs Planned as Well as Some Revisions

Today, the FDA debuted a new page on their website called Upcoming Product-Specific Guidances for Complex Generic Drug Product Development.  Its stated purpose is to provide “information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.”  This comes after several public […]

Read More