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Home » CBER ISSUES FINAL ELECTRONIC SUBMISSION GUIDANCE
CBER ISSUES FINAL ELECTRONIC SUBMISSION GUIDANCE
July 20, 2006
The FDA's Center for Biologics Evaluation and Research (CBER) has 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 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.
Identification information for each lot release protocol should be in a separate PDF file. Lot release information for each lot should be saved in a separate file, 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.
KEYWORDS FDAnews Drug Daily Bulletin
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