💊FDA Product-Specific Guidances for Bioequivalence Studies
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The draft guidances from the FDA regarding bioequivalence studies have significant relevance for businesses in the pharmaceutical industry, requiring compliance with specific regulatory standards for abbreviated new drug applications (ANDAs). This affects how companies design their studies and submit drug applications, directly impacting production processes and market strategy.