Investigational New Drug Review Process

1513 Words Apr 12th, 2013 7 Pages

Investigational New Drug Review Process
Prashanth Kumar Ponugoti
Northeastern University



Investigational New Drug (IND) review process begins from the time the sponsor files investigation new drug application and the purpose of the review is to confirm the safety and efficacy of the patient for the drug. Moreover in the process of review if the review committee notifies any deficiencies by the new drug then there will be a clinical however if there are no deficiencies the drug will be approved for new drug application and will be under continuous review to make sure , that the drug does not cause any potential harm. This entire step
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Medical Review: Medical also called as clinical review is conducted by medical officers or physicians to ensure the initial use of the drug in patients and are safe to use .This review is also conducted by the non medical officers based upon the data available from the re clinical studies. Medical review plays a major role in new drug review process and is an initiating step for the test of the drug in humans: however it is an important step to be conducted and based upon the results obtained from the review it has a further scope to apply for next steps that is to file new drug application. During this review process the medical reviewers or physicians evaluate the clinical trial protocol for to determine A. If the participants will be protected from unnecessary risks; and B. If the study design will provide data relevant to the safety and effectiveness of the drug.
However the safety of the drug is taken by the sponsor during the phase I studies but during phase II, III, and IV Food and Drug Administration (FDA) must also ensure the safety of the medicament in humans for market approval.

IV. Chemistry Review: Each review committee has an chemistry review department for reviewing the chemistry of the drug and the agenda of this chemistry department is to address issues related to drug identity, manufacturing control, and analysis. The reviewing committee ensures that the
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