In an effort to streamline clinical trial processes, and make the results of trials more transparent and accessible to the public, The Department of Health and Human Services (HHS) has recently issued a Final Rule which sets out new clinical trial reporting requirements. ...Read More
Comparator clinical trials are becoming increasingly important for companies that want to prove the effectiveness of their product. Unlike trials that use a placebo, comparator clinical trials compare a new medication to a drug that is already approved for use on the market. ...Read More
The Accelerated Access Review of Innovative Medicines and Medical Technologies (AAR) is a UK health initiative, commissioned by the government in 2014 and developed in partnership with The Wellcome Trust. ...Read More
Biosimilars have become a hot topic recently, with drug prices soaring in the US and patients calling for cheaper alternatives to the brand name drugs that they are forced to buy. But the US is behind when it comes to biosimilars ...Read More
In 2007, the Food and Drug Administration Amendments Act (FDAAA) was passed, and with it the Priority Review Voucher (PRV) system was born. ...Read More
Approved by the House of Representatives last year, the 21st Century Cures Act is currently being considered by the US Senate. It seems to have been the topic of much discussion over the past couple of months ...Read More