Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As
This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML). The guidance also provides information to FDA staff who review and manage product information using electronic systems. This is revision 1 of a guidance of the same name that was issued in December 2005. The guidance has been revised to reflect changes in the technology since 2005 and to harmonize the submission of SPL in the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). We anticipate that additional guidance will be provided as new questions arise about the use of SPL in different contexts.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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