Consultation Programs

The parallel development of a drug and a diagnostic is a relatively new aspect of drug development and calls for careful coordination. FDA has three mechanisms for an early interaction with companies about the use of drug-diagnostic combinations. CDER has developed a new approach for data review referred to as voluntary genomic data submissions (VGDSs). These submissions can be used throughout this development process to present and discuss data with the agency that are not used for regulatory decision making but could have an effect on the overall development strategy. Such data submitted voluntarily will not be used for regulatory decision making by the FDA and is not included in the evaluation of an investigational new drug (IND), investigational device exemption (IDE), or market application. Both CDER and CDRH representatives participate in VGDSs and will work with the sponsor to identify when pre-IDE interactions for development of the test in conjunction with the drug are advisable.

CDER has also developed a pre-IND process for early interactions with a sponsor to improve a development program and expedite entry into clinical trials. Pre-IND advice may be requested for issues related to data needed to support the rationale for testing a drug in humans; the design of nonclinical pharmacology, toxicology, and drug activity studies, including design and potential uses of any proposed treatment studies in animal models; data requirements for an investigational new drug (IND) application; initial drug development plans; and regulatory requirements for demonstrating safety and efficacy. Pre-IND interactions should be considered as preliminary communications based on early development information and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate.

The pre-IDE process is the term CDRH uses for a voluntary system available to sponsors for protocol review and has already been described in this chapter. Additional regulatory tools that CDRH uses to support introduction of new molecular diagnostics and co-development products are expedite review submissions (the front of the queue), the de novo process for regulating new unclassified devices (first of a kind) and real-time reviews by reducing regulatory working time and improving the quality of results (see the Section "Regulatory Tools and Solutions for Pharmacogenomics Markers).

By employing these types of review processes, the intent of CDER and CDRH is to provide useful information to sponsors as they work on co-developed products. The FDA is willing to coordinate work between these reviews as appropriate. The FDA recommends that sponsors of new drug-diagnostic products interact early with the FDA to determine best practice information and current scientific and regulatory thinking.

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