FDA publishes product-specific guidances to facilitate generic drug development Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. Today's batch of 43 PSGs includes: - 30 new and 13 revised PSGs
- 13 PSGs for complex products (11 new and 2 revised PSGs); 11 of these for products with no approved ANDAs (10 new and 1 revised PSGs)
- 34 PSGs for products with no approved ANDAs (23 non-complex and 11 complex products)
- New PSGs for products used as treatments for diseases or conditions, some of which were supported by GDUFA science and research, such as:
- COVID-19 – FDA developed PSGs for remdesivir powder and solution (RLD: VEKLURY, NDA 214787), which are for the drug originally approved in October 2020 for the treatment of certain patients with COVID-19.
- Vasodilatory shock – FDA developed a PSG for vasopressin solution (RLD: Vasostrict, NDA 204485) using GDUFA research on the immunogenicity risk of peptide products. This PSG will facilitate generic development of this life-saving medication, which is also used as a supportive therapy for COVID-19 patients.
- Spinal Muscular Atrophy – Oligonucleotide-based drugs are emerging therapies which present unique challenges for generic drug development. Currently there are no International Conference on Harmonization (ICH) guidelines specifically available for the quality or bioequivalence aspect of oligonucleotide drugs. The PSG for nusinersen sodium intrathecal solution (RLD: SPINRAZA, NDA 209531) is the first for this class of oligonucleotide drugs, which provides the Agency's current thinking on assessing pharmaceutical equivalence and bioequivalence of this complex product. FDA's GDUFA-funded research was instrumental to the development of this PSG.
- Non-small cell lung cancer and prostate cancer
When finalized, the guidances 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 docket before finalizing PSGs. FDA publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate product development resources and prepare more complete submissions, especially for products that do not currently have approved generics. Once these generic products are developed, approved, and marketed, generic competition for these drug products could support greater access to high-quality, safe, effective, and potentially lower-cost treatments. FDA aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high-quality and affordable medicines supports the agency's mission to advance the public health, as outlined in our Drug Competition Action Plan. Newly Updated – Upcoming Complex PSGs Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the agency's plans for issuing new or revised PSGs in the coming year for complex products as defined in the GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs. For more information, to view the guidances, or to submit comments on the PSGs, visit the Federal Register Notice: Product-Specific Guidances. |
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