EMA Seeks Public Consult on Bioequivalence Concept Paper
EMA releases concept paper on development of product-specific guidance on demonstration of bioequivalence.
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The European Medicines Agency has released its draft concept paper on the development of development of product-specific guidance on demonstration of bioequivalence. Public comments are open until September 30.
EMA plans to develop product-specific guidance to enable a consistent approach to the assessment of applications based on bioequivalence data across various submission routes to help companies design study programs that meet European Union regulations. The guidance will be based on EMA’s guideline on the investigation of bioequivalence.
Source: European Medicines Agency
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001866.jsp&mid=WC0b01ac058004d5c1
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.
