FDA Drug Safety Expert
A drug safety expert is familiar with the drug development process of evaluating new and established drugs for safety signals. New Drugs are tested in a limited sample population which should accurately represent the diverse population of patients in the United States. Testing drugs in a specific, non-diverse population, could change the dose or the metabolization characteristics, or even the dose of the drug being tested.Likewise, different populations have been known to metabolize substances remarkably differently, which could require a dosage adjustment for medicines that have a narrow safety window. For this reason, anywhere between 20% to >50% of a Phase 3 population should include the proposed dosing population in the United States.
FormerFDA.com Drug safety experts have extensive pharmacology, medical device safety and clinical trial experience and are well versed in FDA law, clinical trial requirements and regulatory affairs.
In addition to being a drug safety expert for new currently in development FormerFDA has specialists in the FDA’s AERS database. FDA AERS (also knows as ‘FAERS’), or the (FDA) Adverse Event Reporting System, has been collecting adverse events of medicines which have already been approved. FormerFDA.com has access to the AERS/FAERS database, from its inception in 1968 to the latest available quarterly updates.
The accumulated FDA AERS database contains adverse events from every single U.S. marketed since its inception in 1997. It is run by the FDA and is a central depot of adverse events from many different sources including, physicians, pharmacists, nurses, pharmaceutical companies, lawyers or the lay public.
A special request must be made to the FDA in order to access their FDA AERS database, and analysis of FDA AERS data requires special skills. FDA AERS findings must be examined carefully by a drug safety specialist who is familiar with FDA AERS reporting requirements and cataloging methods.
Contact our experienced team of experts here.
Glossary of Terms:
Drug Safety Expert — When drugs are administered to a diverse population, there may be side effects or adverse events of the administered drug. This occurs because the drug is not metabolized in the exact same manner in every single person. Genetic variations in metabolizing enzyme levels can cause different people to experience highly variable clinical effects. Even homogenous-seeming populations such as Korean, Chinese, Japanese and other Asian populations can have wide variances in their metabolism.
A FormerFDA.com Drug Safety Expert can assist you in analyzing drug adverse events.