Today, the OGD published a list of 29 new Product-Specific Guidances (PSGs) and 33 revisions to existing PSGs, all of which have been added since February 15, 2024. The listing can be found here. This publication is different than the one we wrote about in another blog today regarding the FDA’s plans for issuance of new and revised guidances in the coming year or so.
As a caution, be certain to review any products on the revision list to see whether there may be impact to a current product development plan, an ANDA already filed but not yet approved, or an approved ANDA in your portfolio.
