2023
DOI: 10.3389/fmed.2022.1109541
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New science, drug regulation, and emergent public health issues: The work of FDA’s division of applied regulatory science

Abstract: The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse b… Show more

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Cited by 14 publications
(17 citation statements)
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“… The FDA has declared that any product with a PD marker will not need to demonstrate efficacy in patients, even if the PD markers do not correlate with clinical response. 31 However, antibodies do not demonstrate a PD response excluding them from this category. Since the PD response results from receptor binding, should functional studies suffice to qualify for the waiver of Phase 3 studies?…”
Section: Regulatorymentioning
confidence: 99%
See 2 more Smart Citations
“… The FDA has declared that any product with a PD marker will not need to demonstrate efficacy in patients, even if the PD markers do not correlate with clinical response. 31 However, antibodies do not demonstrate a PD response excluding them from this category. Since the PD response results from receptor binding, should functional studies suffice to qualify for the waiver of Phase 3 studies?…”
Section: Regulatorymentioning
confidence: 99%
“…30 The FDA has taken several measures to expedite the development of biosimilars at a much-reduced cost, for example, by suggesting to replace comparative clinical efficacy testing, which adds to almost 70% or more of the development cost, with in silico models. 31 Unnecessary testing in humans is highly discouraged as codified in the US 21 CFR 320.25(a)(13). 32 Therefore, if patient efficacy testing cannot fail, it is tantamount to human abuse.…”
Section: Regulatorymentioning
confidence: 99%
See 1 more Smart Citation
“…After almost 2 decades of biosimilar use worldwide and the experience of regu-latory agencies, there is a need to qualify these clinical efficacy testing studies. 4 Accordingly, similar to other regulatory agencies, the FDA has identified alternative ways of evaluating patient efficacy.…”
mentioning
confidence: 99%
“…In January 2023, the FDA published a pivotal article reporting on clinical trials that support the waiving of clinical efficacy testing in patients if PD biomarkers show high similarity in clinical pharmacology studies conducted on healthy subjects. 4,6 Considering that PD biomarkers are not available for most biological products (eg, monoclonal antibodies [mAbs]), the FDA has further suggested that developers should conduct intensive research using omics technology to identify such biomarkers. The FDA has also provided examples of this exercise, albeit not for mAbs.…”
mentioning
confidence: 99%