CDER Releases Updated Policies Manual on Proprietary Naming of Drugs

To reduce medication errors, CDER on Friday released its revised policies and procedures on proprietary naming of drugs, which are sometimes misidentified because of the way they are spelled or how the names sound.

The MAPP was originally released in September 2009, and this marks the first time the document has been revised. It includes new office names and updates responsibilities and procedures. It also describes procedures that may be submitted for INDS, NDAs, BLAs, efficacy or labeling supplements, and/or ANDA. It also includes FDA’s review performance goals about the naming of drugs.

The FDA says the update is important to help eliminate unclear label abbreviations, acronyms and dose designations, as well as label and packaging designs that can lead to user confusion.

The agency outlined a timetable for the review process, decision-making and performance goals and approvals through various FDA divisions — depending on the applications.

The Proprietary Name Review process starts when the Office of Surveillance and Epidemiology receives a proposed proprietary name submission, and then leads the overall review, seeking advice from other CDER offices as appropriate.

Overall, the OSE’s obligation is to:

  • Manage review of proposed proprietary names, and lead an interdisciplinary review team, including the Office of New Drugs, the Office of Prescription Drug Promotion and other CDER offices.
  • Ensure that discussions and decisions for review of proprietary name requests will be made in accordance with CDER’s policy on differing opinions, and, if necessary, dispute resolution.
  • Ask OND if it has safety concerns and recommendations if there is a potential for misbranding.

Read the new MAPP here: www.fdanews.com/01-08-16-MAPP.pdf. — Joe Cantlupe

 

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