Although biosimilar drugs have been much slower to take off in the US than they have been in the EU, the FDA recognizes the important role these products can play in potentially cutting healthcare costs [...]
For years, Randomized Controlled Trials (RCTs) have been the gold standard for assessing the safety and efficacy of investigational new drugs. These trials are considered the most effective at overcoming bias and yielding high-quality evidence [...]
The FDA has recently announced that the agency is considering loosening the restrictions on off-label drug promotion in the US. Under the current legislation, physicians can prescribe drugs to treat conditions not included on the [...]
Right to Try legislation, which has already been passed in 37 states, is now being considered at the national level. The legislation, which aims to remove the FDA from the equation when granting patients access [...]
FDA commissioner, Scott Gottlieb, has recently announced some new measures being taken to potentially slow the rise of prescription drug prices in the US. Although the FDA does not directly play a role in setting [...]
Last month, the European Medicines Agency (EMA) and European Union healthcare payers came together for the first time to discuss synergies for fostering timely and affordable access to medicines. The meeting took place at the [...]
The FDA has long supported the use of investigational new drugs outside the clinical trial setting to treat unmet medical needs, a process commonly referred to as expanded access or compassionate use. However, the agency [...]