Today, FDA published a new batch of draft product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating evidence to support abbreviated new drug application (ANDA) approvals. FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to safe, effective, and high-quality treatments. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan, and accelerating the development and approval of generic drugs also advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First.
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
When finalized, the PSGs in today’s batch posting will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs.
Newly Updated – Upcoming PSGs
Today, FDA also updated the “Upcoming Product-Specific Guidances for Generic Drug Product Development” web page, which includes new and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions. As stated in the GDUFA III Commitment Letter, 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. See the guidance for industry Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA for more information. The web page also provides information about the agency’s plans for issuing new or revised PSGs in the coming year for all generic drug products (complex and non-complex), along with anticipated publication dates, consistent with FDA’s GDUFA III commitments.
Noteworthy PSGs in Today’s Batch:
- 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, 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