Transgenic and genetically modified animal models are increasingly being used in the study of disease and for the safety assessment of new compounds. Use of these models enhances understanding of the role that specific genes play in biological pathways. The primary...
The increased requirement for combined chronic toxicity and fertility assessment of biologics has led to greater use of sexually mature non-human primates. Older animals have different needs compared to the younger, adolescent animals with which we are used to...
The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. It is interesting...
Both pharmaceutical industry and regulatory professionals acknowledge the importance of balancing timely access to new medicines with the need for thorough review of drug safety and efficacy data. A new study, funded by the Pew Charitable Trusts (to be published in...
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...
An Institute of Medicine (IOM) committee report, recommends that the FDA take proactive steps to continue monitoring drug safety after initial approval and throughout the market lifecycle. Post-market evidence is far greater than what the FDA has when deciding upon...
