New Drug Development - Clinical Hold Decision
A clinical hold is the mechanism that CDER uses when it does not believe, or cannot confirm, that the study can be conducted without unreasonable risk to the subjects /patients. If this occurs, the Center will contact the sponsor within the 30-day initial review period to stop the clinical trial .CDER may either delay the start of an early-phase trial on the basis of information submitted in the IND, or stop an ongoing study based on a review of newly submitted clinical protocols, safety reports, protocol amendments, or other information. When a clinical hold is issued, a sponsor must address the issue that is the basis of the hold before the order is removed.
CDER's authority concerning clinical holds is outlined in Federal regulations. The regulations specify the clinical hold criteria that CDER applies to various phases of clinical testing. In addition, all clinical holds are reviewed by upper management of CDER to assure consistency and scientific quality in the Center's clinical hold decisions.
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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 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 training - factors to be considered - drug development - risk management - intellectual property - pharmacovigilance
