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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An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form (primarily dissolution or drug release)…
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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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Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development…
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Does my product require an Investigational New Drug (IND) application? It’s a simple question, but the answer can have extensive consequences for your development program. In this post, we will…
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One of the most important aspects of any drug development program is the stream of interactions with regulatory authorities like the US Food and Drug Administration (FDA). These interactions can…
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