FDA Submission Research Articles

Amgen v. Transkaryotic Therapies: Case Study of the Interrelatedness Between Patent and FDA Laws

Biotechnology Law ReportVol. 20, No. 4 PapersAmgen v. Transkaryotic Therapies: Case Study of the Interrelatedness Between Patent and FDA LawsJacob HandyJacob HandySearch for more papers by this authorPublished Online:5 Jul 2004https://doi.org/10.1089/07300310152543952AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetails Volume 20Issue 4Aug 2001 To cite this article:Jacob Handy.Amgen v. Transkaryotic Therapies: Case Study of the Interrelatedness Between Patent and FDA Laws.Biotechnology Law Report.Aug 2001.546-551.http://doi.org/10.1089/07300310152543952Published in Volume: 20 Issue 4: July 5, 2004PDF download

Review of clinical studies of CA 27.29 in breast cancer management.

A critical review of CA 27.29 and CA 15-3 is performed in this paper. A review of the literature is undertaken. A review of the FDA submissions for 27.29 for both early stage and monitoring metastatic breast cancer patients is reviewed.

Computerized Management of Clinical Trials and Patient Data: The Clinical Data Manager

AbstractMicrocomputer technology and database management software are beginning to be utilized in the management of clinical trials and patient data. the Clinical Data Manager™ (CDM), is a database management system (DBMS) developed at Harvard University School of Public Health and enhanced by Clinical Data. CDM automates certain tasks associated with the management of clinical trials including enrollment, monitoring of protocol compliance, adverse reaction reporting, results validation, data analysis, and FDA submissions. the placing of microcomputers at local sites to accomplish data entry and reporting facilitates protocol implementation, and enhances trial management. the prime benefits of distributed data management include the accelerated approval and the documentation of the risks and benefits of new drugs and devices.