• Regulatory NewsRegulatory News

    What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

    US regulators are giving the pharmaceutical industry more time to weigh in on a draft guidance released in May 2014 that seeks to establish how new drug products are given their "brand" names. Background The proprietary name for a drug is its "brand" name. For example, the erectile dysfunction drug sildenafil is marketed by Pfizer under the brand name "Viagra." In many cases, the brand name is easier to understand and recall for consumers and healthcare providers alike....
  • Regulatory NewsRegulatory News

    Will FDA Soon Allow Drug Makers to 'Reserve' Drug Names?

    Could a company with a good idea for a drug name "reserve" that name, preventing another company from using it or using another name similar enough to it to create confusion? While the idea has long been advanced by those in industry, the US Food and Drug Administration (FDA) now says it's willing to consider the idea as well, and is soliciting public input on the proposal. Background The process of naming a drug is considerably more difficult than the lay public might ...
  • Regulatory NewsRegulatory News

    EMA Tightens Standards for Drug Naming Requests

    European regulatory officials have tightened the standards for obtaining approval for a drug name, reducing the number of proposed names companies can put forth for consideration at any one time. The change, contained in a revised guideline, on the Acceptability of Names for Human Medicinal Products Processed Through the Centralised Procedure , reduces the number of proposed names that may be sent to the European Medicines Agency (EMA) to two invented names. At...
  • Regulatory NewsRegulatory News

    What's in a Drug Name? FDA Explains in New Draft Guidance

    How should you name a new drug product? That question is the subject of a new draft guidance by the US Food and Drug Administration (FDA), which hopes to help industry in selecting a proprietary name that can clear the agency's various regulatory hurdles. Background The proprietary name for a drug is its "brand" name. For example, the erectile dysfunction drug sildenafil is marketed by Pfizer under the brand name "Viagra." In many cases, the brand name is easier to unde...