Drugs

Group Seeks Clarity on Use-Related Risk Analyses

Biosimilars advocacy group Biosimilars Forum is asking FDA for further information and clarification on certain areas of the agency’s recent draft guidance entitled “Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products.”

Regarding the scope of the guidance, Biosimilars Forum says in just-posted comments that the document needs more clarity on when it “applies to stand-alone drug and biological products (i.e., those that are not part of a combination product).” Biosimilars Forum requests that the agency provide examples of what are the “certain cases” in which the guidance may also apply to stand-alone drug and biologic products. It says this information is critical for sponsors to understand when FDA would expect a use-related risk analysis (URRA) and to plan their development accordingly.

Biosimilars Forum also asked for clarification about the guidance’s position that a URRA is one element in determining whether a human factors (HF) validation study will be required, and other information can also inform the decision as to whether such a study is necessary. It says the guidance “recognized that a comparative analysis (also referred to as a threshold analysis) can also provide important information, and FDA has also conveyed the relevance of other data for design validation (e.g., anthropomorphic data). We encourage FDA to confirm this flexible approach in finalizing the URRA Draft Guidance, and also to broadly consider other sources of supportive information when evaluating whether an HF validation study is necessary. We further request that FDA include additional examples of other types of supportive information when it finalizes the guidance.”

Additionally, the group says the guidance should also provide more information on the interchangeability of biosimilars that have been approved by the agency “because an HF study may not be required since the users would be more familiar with the usage of the drug/device, [and] the HF study would not add any value to the product since the reference product would be of similar make/type.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome