What is an FDA “guidance” and why is that an important Critical Path tool?
FDA guidances contain science-based recommendations that help eliminate uncertainty about what FDA will accept as valid evidence of product safety, product efficacy, and manufacturing quality. The guidance acts as compass that product sponsors can use to design their product development pathways to most efficiently meet FDA requirements. FDA guidances have been shown to improve chances of product success and shorten time to market. For example, FDA adoption of CD4 cell counts and, subsequently, measures of viral load as surrogate markers for anti-HIV drug approvals allowed the rapid clinical development and approval of life-saving antiviral drugs, with time from first human use to market as short as 3.5 years. Guidances greatly simplify effectiveness studies, thus reducing time and costs. Similarly, device guidances have been shown to reduce both product development time and the percent of applications found deficient on the first review cycle. However, FDA cannot develop new guidances
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- What is an FDA "guidance" and why is that an important Critical Path tool?
