FDA releases 4 dozen new and updated PSGs

Regulatory NewsRegulatory News | 08 November 2021 |  By 

Four dozen new or updated product-specific guidances (PSGs) were released Monday by the US Food and Drug Administration (FDA). Along with the new and updated guidances, FDA also issued a newly developed infographic that provides a snapshot of the overall PSG program.
“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,” wrote the agency in its announcement to industry.
The 48 guidance documents released today include 13 PSGs for complex products, including 8 new PSGs. Of these, 10 have no approved ANDAs. In all, the new batch of PSGs includes 28 guidance documents for products that do not have approved ANDAs.
The new draft PSGs include guidances to aid in the development of generics for Amivas’ malaria treatment Artesunate for Injection (artesunate), Esperion’s non-statin cholesterol lowering drug Nexlizet (bempedoic acid), Jazz Pharma’s small cell lung cancer therapy Zepzelca (lurbinectedin), Incyte’s cholangiocarcinoma treatment Pemazyre (pemigatinib), and Biohaven’s migraine therapy Nurtec (rimegepant sulfate), among other reference listed drugs.  
FDA also updated its webpage on upcoming PSGs for complex generic drug product development, showing the agency’s progress in meeting its commitments under the reauthorization of the Generic Drug User Fee Amendments (GDUFA II). On that page, which is updated quarterly as PSGs are released, FDA lays out planned revisions to PSGs and lists which guidances will receive major revisions. Major revisions include such planned additions as further bioequivalence study recommendations or other additional evidence to support generics approval.
Other guidance documents receive minor revisions, such as removing studies or providing less burdensome alternatives to studies that are currently recommended; a third category is slated to receive just an editorial revision to correct grammar or update references. The list of planned revisions includes a brief summary of what aspects of the PSG will be addressed by what level of revision.
FDA still lists 69 complex generic products slated for new PSG development after the Monday update.
In FDA’s GDUFA III commitment letter released last week, FDA is committing to issuing PSGs within 2 years of approval for 50% of complex products and releasing PSGs within 3 years for 75% of complex products. (RELATED: GDUFA III commitment letter details coming changes to FDA's generic review program, Regulatory Focus 02 November 2021)
The new PSG Snapshot, also published Monday, explains what PSGs are and what they do. It also lays out the development timeline for PSGs for newly approved drugs. Infographics detail the number of new and revised PSGs FDA has published by fiscal year, stretching back to 2013; the two-page document also maps out the FDA offices that contribute to development of PSGs.
Federal Register


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you