PROLABELS™ describes drugs with Clinical Outcome Assessment (COA) results available since 1995 on the European Medicines Agency’s (EMA) website and on the US Food and Drug Administration’s (FDA) website.
The main objective of PROLABELS™ is to summarize all the evidence about COA results in the labeling of medical products for disease areas, conditions, and manufacturers.
PROLABELS™ provides a global picture of all the endpoints used to demonstrate the efficacy and other benefits of a product, if at least one COA is included in the label/EPAR study results.
The database includes an in-depth description of the efficacy clinical studies including the design, the results obtained, and the COA information. You will learn which concept of interest was assessed and how the concept of interest was evaluated, in addition to a brief description of any instrument that was used.
PROLABELS™ database is updated once a week in order to give you the latest comprehensive information on medical products. This update includes new marketing authorizations published on the FDA and EMA websites as well as variations of already approved products.
EMA data: EMA publishes online reports for all the drugs approved according to its centralized procedure established since 1995. The European Public Assessment Reports (EPARs) of all approved drug products are examined with special attention to the Summary of Product Characteristics (SPC). To complete our records, clinical studies which included COA endpoints (whether primary or not) are searched and, when necessary, additional information in Scientific Discussion documents is retrieved.
FDA data: FDA publishes online reports for all drugs approved in the United States of America. All product labels of New Drug and Biological Approvals (i.e. NMEs, BLAs, revisions, efficacy supplements) are examined as soon as they are published on the FDA website. Additional information in the Medical Review is retrieved when necessary.
Once COA results are identified in the label, the corresponding medical product is included in PROLABELS™. Then the record is completed by summarizing the following information in five sections.