Today, the FDA published a list titled Upcoming Product-Specific Guidances for Generic Drug Product Development, which can be found here and has two sections:
- Planned New PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)
- Planned Revised PSGs for Complex and Non-Complex Generic Drug Products (Updated February 15, 2024)
Section 1 contains a list of new guidances that the Agency plans to release. It characterizes the products on the list as either complex or non-complex. The list contains a total of 53 proposed guidances, of which 25 are classified as for complex products. The products are listed by Reference Listed Drug (RLD), dosage form, designation of whether the product is the RLD or Reference Standard (RS), complexity designation of the product, and the planned publication date (but recognize these are soft dates and could change).
Section 2 contains a list of 42 planned revisions to existing PSGs, along with an explanation of the proposed changes, 36 of which are for complex products; only three are listed as major changes, with none listed as critical (a critical revision is explained as a “PSG revision [which] includes additional bioequivalence (BE) study(ies) or evidence recommended that is necessary to establish BE and support FDA approval reflecting a change in the safety or effectiveness of the drug product. The critical revision has a potential impact on all ANDAs including the approved applications.” While there are no critical revisions listed, there are three major revisions that may require additional work on behalf of the applicant. The major revision definition is included in the document. After reviewing the types of changes classified as minor, it appears to me that many of the so-called “minor changes” may require additional work by the applicant, either prior to submission of an ANDA or during the application review, or may require supplemental submissions for approved ANDAs. These types of minor changes include things like adding an alternate in vitro option in place of an in vivo study, removing a strength from the study design due to potential safety issues, revising recommendations for device comparisons, etc.
The document also provides the following discussions points:
- How often does the FDA publish new and revised PSGs?
- What information is provided on this web page?
- What do the different planned revision categories mean?
- What is a complex generic drug product?
- How often does FDA update this web page?
Those of you that have been dealing with PSG revisions know the importance of keeping on top of the Agency’s thinking. This document gives industry insight into potential changes that may impact drug development programs, filings, or approved applications. So, keep in mind that an ounce of prevention is worth a pound of cure!
