The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety. The article format addresses 10 common questions and their answers...
Linguamatics, the leader in natural language processing (NLP)-based text mining, announced that the Federal Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has licensed its 12E text mining platform as a discovery and decision support...
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labels may contain information on genomic biomarkers and can describe: Drug exposure and clinical response...
Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939? By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological products. The...
Dr. Janet Woodcock (CDER, FDA) stated that for every 10 drugs that enter Phase I clinical trials, only 1 drug is approved. The cost of bringing an innovative drug to market often requires a decade and a billion dollars of investment. The paradigm where...
