One of the closing sessions at the recent Association for Accessible Medicine’s GRx + Biosimilars conference covered Post-Approval Changes to Complex Generic Drugs. The session included presentations from multiple individuals from FDA, as well as from industry, to provide a breadth of perspective on this subject. As one would expect, the session did offer both […]
While passage of the Continuing Resolution by Congress on September 30, 2022 and corresponding reauthorization of user fees for the different programmatic areas is a relief, the extremely late passage of the Bill leaves FDA and Industry in an awkward position in relation to one of the most important elements of the reauthorization-submission of applications […]
Depending on the context, a year can either seem like an eternity or a rather short period of time; the details and context will always matter. In the draft Guidance for Industry issued on July 22nd (here ), the Office of Generic Drugs (OGD) laid out its expectations for complying with the regulatory requirement for […]
