A 505(b)(2) application is a hybrid of a full new drug application and an abbreviated new drug application. The terms 505(b)(2), 505(b)(1), and 505(j) all refer to sections of the…
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Across the spectrum of therapeutic indications, typically, the majority of new investigational drugs are evaluated in randomized dose-ranging clinical trials. These types of clinical trials enable a reasonable understanding of…
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Over the past decade, at least 30 prodrugs have been approved by the US Food and Drug Administration (FDA). It is likely that prodrugs will continue to be important in…
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Nonclinical study data submitted to the FDA must align with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). The version of data standards for nonclinical studies…
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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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Content updated on April 21, 2021 An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for…
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