Today, the Office of Generic Drugs announced the issuance of 98 Product-Specific Guidances (PSGs). The guidances can be accessed here.

In an email announcing the availability of the newly issued guidances, the FDA said:

“Today’s batch of 98 PSGs (31 New and 67 Revised) contains:

  • 68 PSGs for products with no approved ANDAs (including 31 complex products)
  • 46 PSGs for complex products (7 new and 39 revised PSGs)
  • PSGs for products such as the first-in-class PI3K inhibitor for treatment of breast cancer with PIK3CA mutations, a pan-genotypic direct-acting antiviral, the first FDA-approved treatment for geographic atrophy secondary to age-related macular degeneration, and the first tissue-agnostic approval for treatment of NTRK gene fusion-positive solid tumors
  • Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for opioid use disorder, reduction of risk of major adverse cardiovascular events and excess body weight, and pain associated with diabetic neuropathy among other indications/conditions”

The email also highlighted the following noteworthy guidances in today’s release:

  • “New PSG for buprenorphine subcutaneous extended-release solution indicated for the treatment of opioid use disorder (RLD: BRIXADI, NDA 210136)
  • New PSG for semaglutide oral tablet indicated for the reduction of the risk of major adverse cardiovascular events and reduction of excess body weight (RLD: WEGOVY, [NDA] 218316)
  • Revised PSGs for four modified-release drug products to remove in vitro alcohol dose dumping studies based on new GDUFA-funded research that a therapeutic equivalence assessment can be made without these studies (RLD: THIOLA EC, NDA 211843; RLD: DRIZALMA SPRINKLE, NDA 212516; RLD: CYMBALTA, NDA 021427; RLD: TALICIA, NDA 213004)
  • Revised PSGs for 30 transdermal/topical delivery systems to reduce the need to conduct a sensitization study to limited conditions, e.g., when a proposed generic product has differences in composition compared to the RLD. The change is expected to significantly reduce the number of subjects enrolled in such studies and streamline generic product development.”

Reducing the amount of unnecessary, duplicative human testing has been a long-time goal of the Hatch-Waxman Act. It’s nice to see the provisions of Hatch-Waxman being used, and further recognized, for reducing the testing of normal volunteers in support of bioequivalence determinations when appropriate.

Remember, “eligible applicants may request a PSG teleconference to obtain FDA’s feedback on the potential impact of a new or revised PSG on its development program and a subsequent PSG meeting following feedback received at the PSG teleconference.” One of the difficulties with the issuance of revised guidance is lack of a tracked-changes format where one can easily see the changes from the previous version.