Biologies licensing applications

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

NEW DRUOOR AMTIHIOTtCAPPUCATtON NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMS6R (XpreviOiiSiytSSueO)... 

Change in the fashion biologicals regulated (elimination of the Establishment and Product licenses, both replaced with a Biological License Application or BLA). 

Biologies License Applications (BLAs) for therapeutic biologic drugs... 

The regulatory process is the filing of an IND for clinical trials. At the conclusion of clinical trials, the Sponsor files a Biological License Application (BLA) for marketing approval. The CBER evaluates a biologic in terms of risk versus benefits before approving it for marketing. 

Application and approval process NDA (New Drug Application) PLA (Product License Application) ELA (Establishment License Application) BLA (Biologic License Application)... 

QA/QC specifications are summarized in the Chemistry, Manufacturing, and Contois (CMC) section and in the Established Description sections of the Biologies License Application (BLA) for every recombinant and other biologic product. Additional details on FDA requirements for product specification and QA/QC standards are found in the Guidance for Industry (FDA website— www.fda.gov/cber/guidelines.htm). 

Type of submission Product license application (Ceredase), Biologic license application (Cerezyme)... 

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