Biologics License Application (BLA)
A Biologics License Application (BLA) is handed over to the Food and Drug Administration (FDA) to get the approval of distributing any particular biological product in various states. This is under the regulation of 21 CFR 600-680. The application is submitted by any individual tasked with the responsibility of the safety and efficacy of the product. The submission of BLA requires the applicants to fill the form FDA356h and hand it over to the Center for Biologics Evaluation and Research (CBER) either in hard copies or the softcopies- electronically (Shiva, 2019). The application entails certain information to gain approval.
The application needs to have the following:
- The draft of the product should be labeled.
- The summary of the information deemed necessary in the application and the information that is related to the individual applying for License.
- Preclinical data should be included and the clinical data. The clinical data should consist of the safety of the product and also the product’s efficacy.
- It should have information about the manufacturing of the product and the chemistry of the particular product.
- It should have summarized data that validates the processes which are involved in the product’s manufacturing.
- The application requires a detailed description of the manufacturing company.
- The case reports on the clinical experiences of the manufacturing company
- A detailed description of the severe events and also the forms of case reports
- The index.
A notable difference with the New Drug Application (NDA) and BLA is that the NDA is used for drugs subject to the approval requirements given by the FDA. BLA, on the other hand, is for biological products under the regulation of the PHS Act. NDA requires testing of the drug being observed, unlike in the BLA, which does not request such (Center for Drug Evaluation and Research). The drug should also be stated whether it belongs to humans or animals.