RAPS.org needs your explicit consent to store browser cookies. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Please see our Privacy Policy for more information.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
19 October 2020
Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European Market, said a committee of the European Medicines Agency (EMA) following its scheduled September meetin...

Latest News

ALL
19 October 2020
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...
19 October 2020
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 ...
16 October 2020
Two new pilot programs related to manufacturing quality management have been launched by the US Food and Drug Administration (FDA).  
16 October 2020
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...
16 October 2020
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...
16 October 2020
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.