Zdrowie i gospodarka · 01/06/1998

Draft ``Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations (CRT's) and Data 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Electronic Submissions of Case Report Forms (CRF's), Case Report Tabulations (CRT's) and Data to the Center for Biologics Evaluation and Research.'' This draft guidance document, when finalized, is intended to provide guidance to industry regarding the submission of electronic CRF's and CRT's as part of license applications to the Center for Biologics Evaluation and Research (CBER). This draft guidance document is part of CBER's effort to provide an efficient process for electronic submissions of regulatory information relating to the development and marketing of biological products. Submissions in electronic format are voluntary.