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Zdrowie i gospodarka · 1.06.1998

Draft ``Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research;'' Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Instructions for Submitting Electronic Lot Release Protocols to the Center for Biologics Evaluation and Research.'' The draft guidance document, when finalized, is intended to provide instructions to manufacturers regarding the submission of the electronic protocols to the Center for Biologics Evaluation and Research (CBER). This draft guidance document is part of CBER's continuing effort to develop an efficient process for electronic submissions of regulatory information relating to the development and marketing of biological products. Submissions in electronic format are voluntary.

Source: Federal Register — Food and Drug AdministrationOpen original release →