FDA is asking for more information on application forms: Here ’s why that’s good for innovation and improving health

Christopher Leptak, M.D., Ph.D., is Director, Office of New Drug’s Regulatory Science Program in the FDA’s Center for Drug Evaluation and Research. By: Dr. Christopher Leptak To be most effective, electronic health records (EHRs) use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care. This helps to ensure consistency from EHR to EHR and allows these records to be usable from healthcare entity to health care entity, a concept known as interoperability. This nomenclature, used by both industry and the federal government, is called SNOMED CT. Recognizing the value of such a comprehensive and standard clinical healthcare terminology, the FDA is also embracing the use of SNOMED CT to characterize disease names for its drug development pipeline and for FDA-approved products. The forms drug developers submit in their product applications now request use of this nomenclature. Forms for Investigational New Drugs (INDs) (FDA Form 1571) and New Drug Applications (NDAs), Biologic License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs) (FDA Form 356h) have been revised to request additional supplemental systematized information using the SNOMED CT nomenclature to state for what disease or diseases the drug in the application is indicated. Here’s why the new nomenclature is good for innovation and improved health: By clearly identifying the intended uses or indications for a potential new drug,...
Source: Mass Device - Category: Medical Devices Authors: Tags: Blog FDA Voice Source Type: news