Drugs

Generally Accepted Scientific Knowledge Guidance

FDA has published a draft guidance, Generally Accepted Scientific Knowledge in Applications for Drug and Biological Product: Nonclinical Information, describing instances in which it may be appropriate to rely on GASK (generally accepted scientific knowledge) to meet certain nonclinical safety requirements for NDAs and BLAs. The document says the information that supports the nonclinical safety of a drug and that must be submitted in the application can include references to GASK, when appropriate, instead of, or in addition to, specific studies conducted concerning the drug. “In such cases, therefore, it might be unnecessary to conduct certain nonclinical studies,” the guidance says.

FDA says the guidance focuses on two examples of GASK that could be appropriate to fulfill certain legal and regulatory requirements applicable to the drug or biological product in question. “The examples discussed in this guidance reflect areas where we have previously determined that it was appropriate to rely on GASK to meet certain requirements for approval,” the agency says. “Notably, while the examples provided here are for illustrative purposes, determinations regarding the appropriateness of data submitted for any application, including GASK, are fact-specific, and the question of whether certain information can be considered GASK and the purpose such information would serve in an application will be considered in the context of a particular application.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome