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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.
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.
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (), nicknamed "Bioshield Two" and sponsored by Senator Richard Burr (R-North Carolina), aimed to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries.
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.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. If the file has been modified from its original state, some details may not fully reflect the modified file.
OpenFDA is a project indexing and formatting Food and Drug Administration (FDA) data, and making it accessible to the public. The ultimate goal of enabling the data accessibility is to educate people and save lives. The currently provided API of accessing data is under beta version.
If the file has been modified from its original state, some details may not fully reflect the modified file. Short title Commission Regulation (EC) No 105/2005 of 17 November 2004 amending Council Regulation (EC) No 1420/1999 and Regulation (EC) No 1547/1999 as regards shipments of certain types of waste to China and Saudi Arabia (Text with EEA ...