The Weinberg Blog Bioequivalence and Product-Specific Guidances

The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating the evidence needed to support ANDA approval. These guidances represent the Agency’s current thinking regarding generic drugs and describe expectations on how […] The post Bioequivalence and Product-Specific Guidances appeared first on The Weinberg Group.