While Friday, August 8, 2025 didn’t appear to be different than any other Friday during the summer, it turned out to be a rather momentous date for a few ANDA sponsors. This is because it was the day that the FDA’s Office of Generic Drugs approved three ANDAs for Iron Sucrose Injection as therapeutically equivalent to […]
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 […]
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 […]
