FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development

Upcoming Product-Specific Guidances for Generic Drug Product Development https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specific-guidances-generic-drug-product-development FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry August 2024 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/product-specific-guidance-meetings-between-fda-and-anda-applicants-under-gdufa?utm_medium=email&utm_source=govdelivery 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 81 PSGs (44 New and 37 Revised) contains: 54 PSGs for products with no approved ANDAs (including 19 complex products) 28 PSGs for complex products (7 new and 21 revised PSGs) PSGs for products used for treatment of resistant bacterial infections, cystic fibrosis, lung and thyroid cancer, seizures associated with Dravet syndrome, and other conditions Additional noteworthy PSGs are described below, including PSGs that were supported by GDUFA-funded research. These PSGs reference products used for first-in-class topical therapy for psoriasis patients and treatment of seborrheic dermatitis, wounds associated with dystrophic and junctional epidermolysis bullosa, and other 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 Tomorrow, FDA also will update 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 treatment of seborrheic dermatitis; roflumilast topical foam (RLD: ZORYVE, NDA 217242) New PSG for treatment of rare skin conditions, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa; birch triterpenes topical gel (RLD: FILSUVEZ, NDA 215064) Revised PSG to include a characterization-based BE approach for non-steroidal adjunct therapy for psoriasis; tapinarof topical cream (RLD: VTAMA, NDA 217806) Revised PSGs for multiple modified-release drug products to remove in vitro alcohol dose dumping studies due to new GDUFA-funded research that suggests such studies are not needed: carbinoxamine maleate oral extended release suspension; (RLD: KARBINAL ER NDA 022556); carvedilol phosphate oral extended release capsule (RLD: COREG CR, NDA 022012); diltiazem hydrochloride oral extended release capsule (RLD: CARDIZEM CD, NDA 020062); posaconazole oral delayed release for suspension (RLD: NOXAFIL POWDERMIX KIT, NDA 214770); trospium chloride oral extended release capsule (RLD: SANCTURA XR, NDA 022103) Revised PSGs for complex peptides to clarify recommendations on the conduct of in vitro innate immune response assays, and when recombinant generic peptides can be submitted through the generic pathway. These include calcitonin (RLD: CALCIMAR, NDA 017769); glucagon (RLD: BAQSIMI, GVOKE, NDA 210134, 212097); dasiglucagon (RLD: ZEGALOGUE, NDA 214231); pegcetacoplan (RLD: EMPAVELI, SYFOVRE, NDA 215014, 217171); tirzepatide (RLD: MOUNJARO, NDA 215866); teriparatide (RLD: FORTEO, NDA 021318); liraglutide (RLD: VICTOZA, SAXENDA, NDA 022341, 206321); semaglutide (RLD: WEGOVY, NDA 215256); vosoritide (RLD: VOXZOGO, NDA 214938). FDA Drug Competition Action Plan https://www.fda.gov/drugs/guidance-compliance-regulatory-information/fda-drug-competition-action-plan?utm_medium=email&utm_source=govdelivery