Nonclinical Toxicology: FDA Guidance Agenda for 2012

The Federal Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a list of planned draft and final guidance documents for release in 2012. لعبة الكازينو   There are about 50 such guidances planned.  Below are a few select highlights...

Nonclinical Toxicology Sector Predictions for 2012

Growth in demand for nonclinical toxicology services will be weak for the foreseeable future analysts said after the Society of Toxicology (SOT) annual meeting in San Francisco this past week. كيف تربح في الروليت   “Most agree that the industry is not merely going...

FDA Changes Expected with PDUFA V

The average cost of developing a drug was $1.3 billion as of January 2011.  The average first-cycle approval rate for standard new molecular entities (NME) has increased from an average of 30% in 1992 to 38% this year.  Priority NMEs have fared better with the FDA,...

Nonclinical Cardiotoxicity Testing: Stem Cell Use

Prospective identification and potential amelioration of cardiotoxicity is a critical component of contemporary drug development, particularly for targeted therapies (e.g., tyrosine kinases) in oncology that are designed to inhibit critical signaling pathways shared...