Regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic…
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CDISC stands for the “Clinical Data Interchange Standards Consortium,” and is a global not-for-profit organization that actively develops data standards with the collective knowledge and experience of volunteers within the…
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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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