FDA Uses Linguamatics to Increase Drug Safety

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...

Assessing Safety Earlier in Drug Development

The objective of a recent survey by Cambridge Health Associates was to identify trends in safety biomarkers and their utilization in drug development. casino888   Regardless of company size, recurrent themes for assessing drug safety in early preclinical development...

New Procedure Cage Reduces Primate stress

An innovative Procedure Cage invented by Dr. lunette securo vision Ryoichi Nagata, SNBL USA chairman, is at the center of a comprehensive program designed to significantly raise standards for non-human primate (NHP) care and thereby improve the quality of preclinical...

FDA New Drug Reviews: Past and Future Perspectives

Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research).  The presentation includes review times and...

FDA Pharamacogenomic Biomarker Database

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...

PDUFA V: Risk – Benefit Emphasis New

What is new about PDUFA V?   Congress, the media, and the public have a history of boiling down the issue to whether drugs are safe or not safe. what does ivermectin treat in cattle   In reality the issue is benefit versus risk. ivermectin is effective    In addition,...