An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been…
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To formally request approval to market a new drug in the United States, Sponsors must submit either a New Drug Application (NDA) or a Biologics License Application (BLA) to the…
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There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): Requests for authorization for clinical investigations Requests for marketing approval…
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It’s never too early to start planning for your NDA Begin assembling your NDA early Understand the relevant statutes and regulatory guidelines that apply to your program Use standardized templates…
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Content originally posted April 2016 and updated on October 23, 2019 An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in…
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Clinical trials are a vital aspect of drug development and approval. Whether it be a single-site, Phase 1 study in healthy subjects to understand the safety and pharmacokinetics of a…
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The electronic common technical document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for…
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