Benefits of Utilizing the 505(b)(2) Pathway for Prodrugs
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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Understanding CDISC SEND Data and How to Be Compliant
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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When Should You Hire a Clinical Pharmacologist?
Because of the importance of clinical pharmacology to drug development, it is essential to consider the expertise of your product development team early and to determine whether additional clinical pharmacology…
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CAR T-Cell Therapy Challenges to Development & Approval
Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved…
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What is a 505(b)(2)?
The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
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Understanding Current and Future Therapeutic Options for COVID-19
In recent weeks, the world has welcomed very positive and much anticipated news on the COVID-19 vaccine front. At least two high-profile vaccines (mRNA vaccines from Pfizer/BioNTech and Moderna) have…
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Fostering Inclusion and Diversity in Clinical Trials
Inaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity…
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