CBER Issues Final Guidance On Electronic Submissions

The FDA’s Center for Biologics Evaluation and Research (CBER) earlier this month issued a guidance on how manufacturers of biologic products should submit their lot release protocols in electronic format to CBER’s Product Release Branch.

CBER may require manufacturers to submit samples of any lot of any licensed biologic product for review and testing, together with the protocols showing the results of applicable tests.

The agency is recommending that these submissions be made in electronic format, such as on a floppy disk or CD-ROM.

Each CD-ROM or disk should include a cover letter in PDF format with a description of the submission, a statement that the submission is virus-free and regulatory and technical point- of-contact information.

Details on Identification Information

Identification information for each lot release protocol should be in separate PFD files.

Lot release information for each lot should be saved in separate files, which the agency recommends be named under the old DOS standard that limits the filename to eight characters with an extension of up to three characters.

The first four characters of the filename should be the year, followed by a four-digit sequential submission number for that year, with a two- or three-character extension designating the type of the submission, such as “.P0” (zero) for a submission under the original protocol.

Finally, the agency recommends the use of functional bookmarks to help with navigation within the PDF file. — Martin Gidron