The Brexit Health Alliance has recently released a briefing paper, titled “Brexit and the impact on patient access to medicines and medical technologies”, highlighting the need for regulatory cooperation between the EU and UK, in order [...]
Expanded Access Programs (EAPs), also referred to as Managed Access or Compassionate Use Programs, allow patients with no viable treatment options available to them to access investigational drugs before they are approved for market use. [...]
This week, the FDA announced plans to make clinical trial data more readily available to physicians, patients and researchers, following the approval of new drugs. According to FDA commissioner, Scott Gottlieb, the agency will soon [...]
Earlier this month, the FDA released two documents that will improve aspects of the submission and review processes for generic drug applications, referred to as Abbreviated New Drug Applications (ANDAs). These documents have been created [...]