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The FDA center released a list of the guidance documents it plans to publish in 2015.
FDA’s Center for Drug Evaluation and Research (CDER) has released its guidance agenda for 2015. Among the new and revised draft guidance documents are eight regarding biopharmaceuticals, including four on biosimilarity. Pharmaceutical quality is the hot topic for CDER in 2015 with 16 guidance documents planned for the year, including guidance on quality metrics and elemental impurities. Drug safety, generic drugs, and electronic submissions are topics to be addressed in the new year.
A few noteworthy guidance documents for 2015 include:
For a complete list of guidance documents CDER has planned for 2015, visit FDA.gov.