CDER Releases List of Upcoming Guidance Documents

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) released 5 March a list of all new and revised guidance documents that the agency plans to release during 2012.

The list contains guidance documents related to:

• advertising
• biopharmaceuticals
• biosimilarity
• chemistry
• clinical/antimicrobial
• clinical pharmacology
• clinical/statistical
• combination products
• current good manufacturing practices/compliance
• drug safety information
• electronic submissions
• Investigational new drugs
• labeling and procedures.

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