The recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the 7 protein biomarker panel for use in detecting drug-induced kidney damage means that the biomarkers are now qualified at the same level by all of the ICH regulatory agencies....
Face it, the Food and Drug Administration’s (FDA) website is not the most user friendly of Regulatory options! For the incredibly low price of $30 USD you can now have a comprehensive superset of 4 CD‑ROMs which provide an up-to-date collection of documents, manuals,...
On 19 May 2010, a FDA task force proposed 21 ways that the Agency could release more information to the public in areas like drug evaluation, including information about safety problems with the drugs and devices it rejects. Although the FDA has long operated under...
Rare diseases can be described in terms of incidence, etiology, morbidity, and survival. Incidence can vary, however, from rare (e.g., Gaucher disease, cystic fibrosis) to epidemic proportions (e.g., HIV, malaria, cholera). The incidence of less frequently occurring...
Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including 7 years’ marketing exclusivity and tax breaks. Last year, just 250 requests for orphan-drug designation were filed, and 160 were...
The Federal Register and the ICH S9 Guidance for the nonclinical evaluation for anticancer pharmaceuticals issued today. The guidance provides recommendations for preclinical studies for the development of pharmaceuticals, including both drugs and biotechnology...
