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The FDA released a draft guidance (M13B) that lets drug makers request waivers so they do not have to run extra in vivo bioequivalence (BE) studies for additional strengths of immediate-release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 The draft guidance was prepared under the International Council for Harmonisation and builds on the M13A final guidance published in October 2024; this could save time and money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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-09767 — Oscar Bobo: Final Debarment Order
Oscar Bobo is officially banned for 5 years from importing any drugs into the U.S. because he repeatedly brought in mislabeled medicines that don’t follow FDA rules. He ignored the chance to defend himself, so the ban started on May 15, 2026. This means no drug imports from him for a while, but he can apply to end the ban anytime if he meets FDA’s conditions.
2026-09448 — Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
The FDA is asking for approval to collect info for the third group in its Real Cost Campaign, which teaches kids about the dangers of tobacco. This helps the FDA improve its anti-smoking messages and protect young people’s health. Comments on this info collection are open until June 12, 2026, with no new costs for participants.
2026-09543 — Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting
The FDA wants your thoughts on how drug companies report problems after their products hit the market. This affects drug makers and healthcare folks who keep track of side effects. They’re asking for comments by July 13, 2026, to help improve the process without adding extra costs or paperwork.
2026-09544 — Modified Risk Tobacco Product Application: Renewal Applications for VLN® King and VLN® Menthol King, Cigarette Products Submitted by 22nd Century Group Inc.
The FDA is inviting the public to comment on the renewal of special approval for two cigarette products by 22nd Century Group Inc. These products claim to lower health risks compared to regular cigarettes. If approved, the renewal keeps these products on the market with their modified risk status, affecting smokers and the tobacco industry starting May 13, 2026.
2026-09335 — Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
Hey there! This update is all about a new medical device that helps doctors quickly find germs and their resistance traits in people who might have bone infections. It affects hospitals and labs by officially classifying this device, making it easier and faster to diagnose tough infections. The change kicks in soon, helping patients get the right treatment without delay—and it could save money by avoiding wrong meds!
2026-09368 — Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization; Guidance for Industry; Availability
The FDA is setting clear rules for certain new tobacco products like e-cigarettes and nicotine pouches that don’t have official approval yet. Companies selling these products without permission might face enforcement actions starting now, so they need to get authorized or risk penalties. This helps protect public health and keeps the market fair and safe.
Previous / Next Documents
Previous: 2025-09899 — Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Mississippi
President just declared a major disaster for Mississippi because of big storms, strong winds, tornadoes, and flooding. This means local communities can get special help to fix public buildings and services. The aid starts now, so Mississippi can bounce back faster and stronger!
Next: 2025-09901 — Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA says epinephrine prefilled syringes for IV use weren’t pulled from the market because of safety or effectiveness problems. This means drug makers can keep getting approval to sell similar versions, so patients and healthcare providers won’t face shortages. No changes in cost or timing are expected, just smooth sailing ahead for this important medicine.