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    Are you ready to begin planning your IND?

    Submitting an Investigational New Drug (IND) application to the US Food and Drug Adminstration is a significant step in the development of a new drug or biologic product. But how do you know when it is time to begin the process of preparing and submitting your IND?  In a webinar replay, Veristat experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND. V...
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    Understanding the purpose of an IND

    Opening an Investigational New Drug (IND) application dossier can allow a sponsor to take advantage of the FDA’s drug development expertise and ensure the development program will meet the agency’s expectations at the time of the marketing application. In a webinar replay, Veristat experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND. View the webina...
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    The regulatory response to COVID-19 was rapid and coordinated

    Rapid reviews, flexible operations and virtual processes by regulatory authorities worldwide during the COVID-19 pandemic have been critical to guide non-pharmaceutical interventions, deploy vaccines and therapeutics, ensure adequate supply of protective equipment and pharmaceutical ingredients, and minimize disruptions to clinical trials for other diseases.   Preventing transmission via non-pharmaceutical interventions Agencies such as the US Food and Drug Administr...