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Revised Draft Guidance: Formal Meetings with the FDA for Drug Products

On 29 December 2017, the FDA released a revised draft guidance “Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.”  This draft guidance replaces the previous draft guidance posted in 2015 on this topic.  According to the draft guidance, from this point in time there will be 4 types of formal meetings with FDA staff. Read more to get the details on each one.

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Could Your Drug Development Program Benefit from an NDA/BLA/PMA Gap Analysis?

Whether you plan to file a new drug application (NDA), a biologics license application (BLA), or a premarket approval application (PMA) with the FDA or a marketing authorization application (MAA) with the European Medicines Agency, you’ll need an in depth understanding of how the data you have from your clinical studies, nonclinical studies, and Chemistry, Manufacturing and Controls (CMC) / Quality development map to the requirements of the application.

Genna Kingon
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10-Step Commercial Clinical Protocol Authoring Guide

Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success.  The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

Heather Kopetski
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FDA Guidance on Non-Inferiority Clinical Trials to Establish Effectiveness

In November 2016, the FDA released final guidance  on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.