Biologies Master Files

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

Master Files submitted in support of products regulated by CBER should be submitted as Biologies Master Files. See the CBER Web site for the products regulated by CBER. 

A description of the history of the ceU line - as well as study protocols and reports of all safety studies carried with the cell line - has been filed as a Biologies Master File at CBER. 

Food and Drug Administration. Guidance for Industry, Submitting Type V Drug Master Files to the Center for Biologies Evaluation and Research, FDA, Rockville, MD, 2001. 

Container/Closure System. A description of the container and closure system and its compatibility with the drug substance should be submitted. The section should include detailed information concerning the supplier and the results of compatibility, toxicity, and biologic tests. Alternatively, a drug master file (DMF) may be referenced for this information. 

Part II relates to the quality of the product and gives details of its chemical, pharmaceutical and biological testing. Data should be provided in respect of qualitative and quantitative particulars of the constituents, description of the method of preparation, control of starting materials, control tests on intermediate products, control tests on the finished product and stability tests. In cases where the active ingredient is made by a manufacturer other than the applicant or the product manufacturer, some of the information required in Part II may be presented in a separate file, the Drug Master File, to maintain the confidential nature of the synthetic process. 

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