What are the Regulatory Differences Between an NDA and BLA?
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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5 Common FDA Applications for Drugs & Biologics
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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9 Tips for Preparing a Successful New Drug Application (NDA)
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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What is IVIVC?
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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Best Practices in Clinical Study Protocol Writing
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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eCTD Regulatory Submissions: Hints & Common Mistakes to Avoid
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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Understanding the Value of a Gap Analysis in Drug Development
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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