Pearls of Wisdom
FDA provides key considerations for COVID-19 vaccines in new guidance, includes 50% efficacy endpoint
The United States Food and Drug Administration (FDA) issued a new guidance for industry related to the Coronavirus Disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2). FDA issued the guidance, titled “Development and...
How Not to Annoy Your [FDA] Reviewer – Robert Seevers will lead RAPS Indiana Chapter webcast
Robert Seevers, Senior Advisor at Pearl Pathways, will lead the RAPS Indiana Chapter webcast on Thursday, April 30.Session description: Eat your lunch and join the RAPS Indiana Chapter online for tips and tricks on how to build a positive relationship with...
Working with FDA in the Time of COVID-19
The United States Food and Drug Administration has taken a beating in recent weeks over its role in the country’s efforts to combat the COVID-19 virus. The concerns have been focused on two basic areas:delays in approving tests for use in diagnosing the...
Active COVID-19 Clinical Trials
With the pandemic of COVID-19 affecting the way of life across the globe, companies continue to accelerate the clinical development of a vaccine or a therapeutic. The number of Covid-19 clinical trials has been steadily growing because of the increases in...
The Simple, Powerful Question That Drug and Device Developers Should Ask Their Regulatory Consultant
You have just been told by a regulatory consultant or trusted advisor that you have to perform a particular study to get your drug or device clinical trial or marketing application approved. And then you ask yourself, “Where does it say that I have to do...