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. In reality the issue is benefit versus risk. In addition, this judgement needs to be aligned with that of the patients...
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...
Many drug hypersensitivity reactions are HLA-linked, meaning that they will occur much more often or even exclusively in individuals who have certain variants of the HLA gene. A new study elucidates the specific mechanism leading to HLA gene-linked hypersensitivity...
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...
