#FDA Tag

The Food and Drug Administration (FDA) has published draft guidance entitled “Medical Gases—Current Good Manufacturing Practice” to help manufacturers of medical gases comply with tailored current Good Manufacturing Practices (cGMP) requirements (codified in 21 CFR part 213), that become effective on December 18, 2025.

The conforming amendments to the cGMP requirements for combination products will take effect on February 2, 2026.

This new draft guidance amends and replaces the draft guideline entitled “Current Good Manufacturing Practices for Medical Gases” published in June 2017, and has been drafted to reflect new and revised regulations in various areas, with the aim of reducing, as appropriate, the regulatory burden for the medical gas industry.

Unlike standard pharmaceuticals, medical gases have unique production, storage, and distribution characteristics (e.g. sealed pressurised systems, reusable cylinders, and no typical ‘expiration’ concerns).

These regulations contain the minimum requirements to ensure that manufacturing processes operate according to acceptable quality standards, but are more specifically tailored to the methods of manufacturing, packaging, labeling, storage, and distribution of medical gases.

In addition to aligning with the unique nature of medical gases, the updated regulations include certification and labeling requirements (e.g., warnings statements on oxygen containers) and modified safety reporting provisions.

Comments on the draft guidance may be submitted in electronic or paper format by January 30, 2026.

SOURCES:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-gases-current-good-manufacturing-practice

On October 29, 2025, the FDA published new draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” The draft guidance includes the recommendations of the FDA in cases where sponsors should consider a simplified approach to biosimilar development and therefore waive conducting a clinical efficacy study to support of a biosimilar application.

This draft guidance highlights recommendations for demonstrating biosimilarity to a reference product, pointing out that following comparative analytical testing, pharmacokinetic (PK) and pharmacodynamic (PD) testing, and in the presence of a clinical immunogenicity assessment demonstrating a high degree of similarity and the absence of clinically significant differences between the proposed product and the reference product, Comparative Efficacy Studies (CES) are not necessary.

The FDA advises considering a simplified approach when:

• the reference product and proposed biosimilar product are manufactured from clonal cell lines, are highly purified, and can be well-characterized analytically;
• the relationship between quality attributes and clinical efficacy is generally understood for the reference product, and these attributes can be evaluated by assays included in the CAA;
• a human pharmacokinetic similarity study is feasible and clinically relevant.

Comparative efficacy studies are therefore only needed to resolve cases of “residual uncertainty” or for products for which clinical endpoints or PK data are not feasible or clinically relevant.

The new draft guidance indicates that the agency now considers comparative clinical efficacy studies to be the exception rather than the rule for biosimilar development programs, at least for therapeutic protein products.

SOURCES:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations