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Agency official outlines FDA PSG updates, easing BE study requirements for many immediate-release drugs
Summary
An FDA agency official told a workshop that PSG updates following the M13a guidance have led the agency to recommend one BE study for a majority of immediate-release oral products, a change intended to reduce applicant burden. The presenter emphasized PSGs are guidance, not requirements.
An agency official representing the U.S. Food and Drug Administration told a workshop audience on Aug. 3 that the agency has revised a large number of product-specific guidances (PSGs) following implementation of the M13a guidance in October 2024. The presenter said the changes aim to clarify recommendations and reduce development burden for applicants.
"So we are reducing the burden on the applicant, in terms of, submitting the ANDA for the IR products, where you can only submit the 1 BE study," the presenter said. The official said the division has updated over 800 PSGs and is "approaching 1,500 PSGs on the IR products," adding that about 77% of those PSGs recommend a single bioequivalence (BE) study rather than two.
The presenter framed the updates as part of a broader effort to be proactive and transparent in PSG wording so applicants understand the reasons behind recommendations. The official emphasized that PSGs are guidance and not mandatory: "guidances are guidances," and applicants may propose alternative BE approaches with supporting justification.
The presenter closed by saying the agency reviews submitted questions and will revise PSGs when warranted, then invited the next speaker, Dr. Rajesh. The workshop included related presentations on M13a recommendations and suitability petitions earlier in the afternoon.
