FDA releases 43 new and revised product-specific guidances

Regulatory NewsRegulatory News | 17 February 2022 |  By 

The US Food and Drug Administration (FDA) on Thursday released its latest quarterly batch of product-specific guidances (PSGs) to support generic drug development. A total of 43 guidance documents were issued, including 30 new and 13 revised PSGs.
These PSGs “provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs),” said an FDA notice.
The PSGs are published as part of FDA’s review commitments under the Generic Drug User Fee Amendments (GDUFA II) program.
In the commitment letter for the upcoming GDUFA III program, FDA agreed to step up its PSG efforts. Under the next iteration of the program, FDA said it will issue PSGs for 50% of new complex products within two years after approval and for 75% of such products within three years after approval beginning in FY 2023, as well as for 90% of non-complex products within two years after approval, for products approved on or after 1 October 2022. (RELATED: GDUFA III commitment letter details coming changes to FDA’s generic review program, Regulatory Focus 2 November 2021)
The prior PSG update was announced in November 2021. (RELATED: FDA releases 4 dozen new and updated PSGs, Regulatory Focus 8 November 2021)
The 43 guidance documents include 30 new and 13 revised PSGs. It includes 13 PSGs for complex products, including 11 new and 2 revised documents. The update includes 34 PSGs for products that do not have approved ANDAs.
Among the new PSGs is a guidance to support the development of generic versions of Gilead’s COVID-19 treatment Veklury (remdesivir), approved in October 2020. Another is a guidance to spur generic versions of Endo International’s Vasostrict (vasopressin) for treating vasodilatory shock. The product is also used as a supportive therapy for COVID-19 patients, said FDA.
Another is a PSG to support generic versions of Biogen’s Spinraza’s (nusinersen sodium), an oligonucleotide-based drug for treating spinal muscular atrophy. FDA announced this guidance is a “first” for this class of drugs. “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.” This guidance was developed through GDUFA-funded research, said the agency.
A total number of 1,978 PSGs have been published, according to FDA’s PSG website.
FDA notice


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