Toxicological Insights for the Global Pharmaceutical Industry
In examining drug safety, the PDUFA V legislation places new emphasis on the risk vs. benefit of new drugs.
Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939?
Researchers find new way to screen drugs for adverse hypersensitivity reactions before use.
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 sexually mature primates in toxicology is providing new opportunities and challenges.
The 10 drugs with the largest number of adverse event reports sent directly to the FDA in 2011 are detailed.
The US FDA leads its EU and Canadian regulatory counterparts in approving more novel drug applications faster over the last decade.
The FDA encourages academic researchers to drive changes in the required testing paradigms (nonclinical and clinical) to enable faster, better, and cheaper drug approvals.
An Institute of Medicine (IOM) committee report makes pharmacovigilance recommendations and favors centralization of drug safety data.
Preclinical offshoring is anticipated to continue for 2-5 years for early Discovery and non-GLP Toxicology studies, despite narrowing price differentials.