Correction/Clarification about FDA Review Documents

Correction/Clarification about FDA Review Documents

Erick Turner Emma Veitch cites my PLoS Medicine Essay [1] about how the Food and Drug Administration’s (FDA’s) review of documents can serve as a source of clinical trials data, but she follows it up with the statement, “However, it is diffi cult to have confi dence in data released by sponsors when the data have not been subjected to external, independent peer review. Furthermore, this informa...

FDA to review "missing" drug company documents.

A Review of FDA Guidance

16.15.03-022010 Introduction Following publication of the December 2008 FDA Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes, assessment of cardiovascular safety has become a critical focus during the development of new antidiabetic therapies for Type 2 diabetes mellitus (T2DM). The importance of this guidance docume...

Writing Web Documents about Films

This paper describes our experiences our experience in building and using a Web-based video library designed for educational use. The CAETI Internet Multimedia Library’s initial audience is K-12 schools; most of the content of our library comes from news and politics-related historical footage. The video library is a good tool not just for content but also for acquiring visual literacy. Politic...

About Machine-Readable Travel Documents

Passports are documents that help immigration officers to identify people. In order to strongly authenticate their data and to automatically identify people, they are now equipped with RFID chips. These contain private information, biometrics, and a digital signature by issuing authorities. Although they substantially increase security at the border controls, they also come with new security an...