Data integrity issues and “pandemic-induced protocol deviations” are a concern for oncology trial sponsors and FDA alike, and the agency has been attempting to be as flexible as is possible while safeguarding patient wellbeing and clinical trial i...

Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s)slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for ...

Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).  

The emergency use authorization (EUA) for certain types of filtering face-piece respirators has been reissued by the US Food and Drug Administration (FDA) as the public health emergency of the COVID-19 pandemic continues. However, only respirators...

With negotiations underway for the next iterations of the US Food and Drug Administration’s (FDA) new and generic drug user fee programs, top officials from the Center for Drug Evaluation and Research (CDER) discussed budget and staffing prioritie...

The European Commission (EC) has set out key steps for effective strategies member states should use to deploy vaccines against COVID-19 when they become available.