Regulatory Roundup, Week of November 19, 2012

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USP announces new drug naming policy and FDA releases two guidance documents.

The United States Pharmacopeial Convention (USP) has announced a new drug naming policy to take affect May 1, 2013. USP worked on the new policy with FDA and industry stakeholders to clarify naming practices for medicines and make them more consistent. According to USP, “the policy will apply prospectively to drug product and compounded preparation monographs that appear in USP’s compendia of public quality standards—the United States Pharmacopeia and National Formulary (USP–NF).”  For more information, visit USP’s website at

USP has also announced its “Fifth Bioassay Workshop,” which will be held on Dec. 4-5, 2012 at USP headquarters in Rockville, MD. The workshop will focus on the development, monitoring, and validation of bioassays. Visit USP's website for more information.

FDA has made available, Guidance on Q11 Development and Manufacture of Drug Substances. FDA intends the guidance to “harmonize the scientific and technical principals relating to the description and justification of the development and manufacturing process of drug substances….”  


Also released by FDA on November 19, 2012 is Guidance for Industry, Electronic Source Data in Clinical Investigations.