Drugs

Demonstrating Effectiveness Guidance for Drugs, Biologics

FDA has issued a draft guidance, Demonstrating Substantial Evidence of Equivalence for Human Drug and Biological Products, to guide applicants planning to file NDAs or BLAs or supplemental applications on the evidence to be provided to demonstrate effectiveness. The document complements and expands on a 1998 guidance.

The guidance says that although the agency’s evidentiary standard for effectiveness has not changed since 1998, the evolution of drug development and science has led to changes in the types of drug development programs submitted to FDA. “Specifically,” it says, “there are more programs studying serious diseases lacking effective treatment, more programs in rare diseases, and more programs for therapies targeted at disease subsets. There is a need for more agency guidance on the flexibility in the amount and type of evidence needed to meet the substantial evidence standard in these circumstances. The approaches discussed in this guidance can yield evidence that meets the statutory standard for substantial evidence and reflect the evolving landscape of drug development.”

The document includes an Introduction, Standard of Effectiveness for Drugs and Biologics, The Quality of Clinical Evidence to Establish Effectiveness, and Examples of Clinical Circumstances Where Additional Flexibility May be Warranted.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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