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,...

FDA Resource for Approved Drug Information

Ever wanted to know the ins and outs of almost every drug approved by the Food and Drug Administration since 1939? قوانين البوكر By using the Drugs@FDA database, you can search for information about FDA-approved brand name and generic drugs and therapeutic biological...

New Hypersensitivity Screen for Drugs

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. العاب بوكر اون لاين   A new study elucidates the specific mechanism leading to HLA...

Preclinical Safety Testing: Use of Transgenic Animals

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. كازينو كبار...