account_balance HHS Privacy and Security Warning Banner

• This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
• This system is provided for Government-authorized use only.
• Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
• Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
• By using this system, you understand and consent to the following:
  • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
  • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.

account_balance Phonetic and Orthographic Computer Analysis (POCA) Software User Agreement

In an effort to minimize the risk of medication errors due to proprietary name confusion, the FDA performs comprehensive safety reviews of proposed proprietary names for all drug and biologic applications it receives each year. Safety reviews include the use of the Phonetic and Orthographic Computer Analysis (POCA) software that uses an algorithm to calculate orthographic and phonetic similarity scores for name pairs. Higher scores indicate name pairs that are more similar and more likely to be confused. This is just one part of the review process the FDA uses in determining the risk of name confusion for a name pair. Providing this software algorithm to the public allows sponsors to screen proposed proprietary names for high similarity scores prior to submitting proposed proprietary names to the Agency for review. This software application uses Drugs@FDA and RxNorm as the two data sources with marketed names that are updated monthly. Additional search capabilities provided in POCA include the United States Adopted Names (USAN) Council stem search algorithm and the non-proprietary name biologic suffix search tool. The latter allows users to search candidate suffixes against suffixes that are already approved and marketed for orthographic and phonetic similarity. This system will not store searches performed by users and provides the necessary security to maintain proprietary information confidentially for each user. Users may access this system anonymously and no user personal information is intercepted or monitored by this system.

Use of this system and/or attainment of a certain POCA score does not guarantee any result with respect to FDA’s determination regarding the safety of a proposed proprietary name. Use of this system is for the user’s evaluation only. Such use does not establish or reserve any rights to proposed proprietary names.