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An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.
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The CTD is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30. The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device.
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.
This file is licensed under the United Kingdom Open Government Licence v3.0.: You are free to: copy, publish, distribute and transmit the Information; adapt the Information; ...
Commission Regulation (EC) No 2027/2005 of 13 December 2005 opening for the year 2006 a tariff quota applicable to the importation into the European Community of certain goods originating in Iceland resulting from the processing of agricultural products covered by Council Regulation (EC) No 3448/93