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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Currently, there is a need for novel cancer therapies. This is due not only to the prevalence and biological complexity of this class of diseases but also to the intractability…
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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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Real-world data (RWD) are data that come from sources other than traditional clinical trials and are becoming increasingly important to today’s healthcare decisions. Historically, drug developers have been limited to…
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In order to be approved by the FDA, a drug must be both safe and effective for the indication(s) and conditions of use stated in its prescribing information (i.e., product…
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Drug applications go through comprehensive reviews of both nonclinical and clinical study data. Historically, these datasets were structured according to the Sponsors’ preferences rather than by standardized criteria, which caused…
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Drug development is resource intensive. It typically takes years, an army of drug development professionals, and significant financial investment to get a single drug from concept to approval. However, even…
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