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...
The Medicines and Healthcare products Regulatory Agency (MHRA) website now provides a new and easy to use directory for the pharmaceutical industry. Highlights include: News and hot topics Contacting the MHRA Fees Legislation, guidance, and policy Clinical trials...
In general, drugs often work in only half of the people who take them. In addition, billions are spent to treat adverse drug reactions and other complications. The personalized medicine approach is to elucidate the differences between patients who respond to a drug...
