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FDA presenter explains Product Specific Guidance program for generic drugs
Summary
An FDA presenter outlined the Product Specific Guidance (PSG) program, saying PSGs reflect the agency's "current thinking" on how to develop therapeutically equivalent generics and noting more than 2,400 PSGs are posted. The talk covered publication cadence, revision categories and engagement routes for industry.
A presenter from the U.S. Food and Drug Administration described Product Specific Guidance (PSG) as "individual guidances that reflect FDA's current thinking and expectations on how to develop a generic drug product that is therapeutically equivalent to its reference listed drug or RLD." The presenter said PSGs are intended to give product‑specific recommendations on studies and methodology applicants should include in abbreviated new drug applications (ANDAs).
The presentation noted PSGs began in 2007 and that "more than 2,400 PSGs are posted as of this month," with the agency typically publishing about 100–200 new or revised PSGs per year. The presenter also pointed attendees to the PSG landing page and forecast list for planned publications and revisions, and encouraged applicants to use public requests, leave comments on draft PSGs and request PSG teleconferences when applicable.
