New Drug Application - Statistical Review
Statisticians evaluate the statistical relevance of the data in the NDA with the main tasks of evaluating the methods used to conduct studies and the various methods used to analyze the data. The purpose of these evaluations is to give the medical officers a better idea of the power of the findings to be extrapolated to the larger patient population in the country.
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3-hr Virtual Seminar: An Introduction to the FDA New Drug Approval Process
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.
Biomarkers for Drug Development: The Emerging Regulatory Landscape
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
This training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.
Drug Safety Assessment and Risk Minimization in the Development Period
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
Drug safety training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
