FDA Draft Eases Testing for Pill Strength Variations
Published Date: 6/2/2025
Notice
Summary
The FDA just dropped a draft guide to help drug makers skip extra tests for different pill strengths if one strength already proved it works. This means faster approvals and less hassle for companies making immediate-release tablets and capsules. If you’re in the drug biz, keep an eye out—this could save time and money starting late 2024!
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Skip extra tests for extra pill strengths
The FDA released a draft guidance (M13B) that lets drug makers request waivers so they do not have to run extra in vivo bioequivalence (BE) studies for additional strengths of immediate-release tablets, capsules, and granules/powders for oral suspension when at least one strength already shows BE. The draft guidance was prepared under the International Council for Harmonisation and builds on the M13A final guidance published in October 2024; this could save time and money for companies starting in late 2024.
Sets harmonized criteria for biowaivers
The draft M13B guidance describes scientific and technical study-design and data-analysis criteria to support bioequivalence assessments and biowaivers for additional strengths, providing harmonized criteria for drug applications with multiple strengths. The guidance is under the ICH and refers to using the principles in the final M13A guidance published in October 2024.
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