Once approved, annual reports, adverse event reports, manufacturing changes and labelling changes must be submitted. An BLA is submitted after the authorization of a new investigational drug. If there is no information in form 356h, the FDA responds within 74 days.  A BLA states that the product is „safe, pure and potent“, that the production sites are unsponsible and that each package of the product bears the license number. Some responses even said that you should not agree on a BLA at all, but only use an SLA according to ITIL. This only confirmed my statement that most IT organizations are still technology-oriented and don`t master the level of service, let alone the customer level. In particular, USM supports the integration of support disciplines in the form of integrated shared service centers in order to achieve a significantly higher service management tool and implement organizational improvement projects faster and at a lower cost with a lasting effect. More Details: USM Portal A biologica license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologica license application is an application for authorization to import or deliver a biologic product in intergovernmental commerce (21 CFR 601.2). . . .