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FDA issues Independent Consultant Guidelines
FDA issued a guidance document describing a program that allows biotechnology companies to request an independent consultant take part in clinical trial protocol review.
Why does FDA allow for an Independent Consultant to participate in the Clinical Trial Protocol Review?
Truly innovative biotechnology investigational new drug (Ind) or new drug applications (Nda) may involve mechanisms so novel that the requisite expertise is not found in-house in FDA.
What Investigational New Drug (Ind) and New Drug Applications are eligible for Independent Consultant participation?
To be eligible, the product must be biologically derived; it must have the potential to advance the treatment, diagnosis or prevention of a disease of addresses an unmet medical need; and the clinical study to be reviewed must be intended to serve as the primary basis of an efficacy claim.
What other requirements apply to use of Independent Consultant in FDA Clinical Trial Protocol Review?
FDA said that a request for an independent consultant could extend a product’s Pdufa* date by up to 60 days. A company may use an independent consultant in this way, as part of a clinical trial protocol review, only once during the development of a product. Companies may recommend consultants for consideration, but FDA will make the final decision.
CBER Guidances Guidelines Points to Consider in use of Independent (Toxicology) Consultants
*Pdufa: Prescription Drug User Fee Act of 1992
Guidance for Industry Independent Consultants for Biotechnology Clinical Trial Protocols
See also: Toxicology Consultants Genetic Engineering, Biotechnology, Biologics