The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: M5 Data Elements and Standards for Drug Dictionaries



It is desirable for regulators and pharmaceutical industry to engage in an intensive information exchange during the drug development phase, the drug evaluation and approval phase and the post-authorization phase

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GMP Conferences by Topics

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