Excerpt
The Center for Research Innovation in Biotechnology (CRIB) is dedicated to identifying trends in the development and approval of new medicines by the U.S. Food and Drug Administration (FDA). We annually update the drug development community about key changes gleaned from our assessment of public documentation provided by the FDA's Orange Book (approvals by the Center for Drug Evaluation and Research; CDER) and Purple Book (licenses granted by Center for Biologics Evaluation and Review; CBER) books.
We also capture and analyze information from the NIH's database, ClinicalTrials.gov. These data pertain to investigative medicines that have been the subject of human clinical trials in the United States and other participating nations. In all cases, extensive disambiguation is required to resolve inaccuracies, ambiguities and typographic errors that are replete throughout these databases.
For this update, we focused upon key trends as informed by the Clinical Drug Experience Knowledgebase (or CDEK). All find- ings can be readily obtained and verified at our website: CDEK. pharmacy.purdue.edu, which provides free and transparent access to these and other information about investigational and approved medicines, their sponsors, intended indications and other publicly available data.