Blog
US FDA’s biosimilar guidance has some people concerned
After the recent issuing of three final guidance’s by the US FDA, there have been many speculations. Some supporter favor these final documents, while others fear the documents led to the risk of “taking a copycat product.” There are two main groups that reached out...
EMA wants stakeholders’ opinions for clinical trials database
Recently, the European Medicines Agency (EMA) sent out a survey to its stakeholders asking for their opinion regarding a new clinical trials database design. The rationale for EMA asking its stakeholders for their opinions is due to new regulations that were created...
Outstanding Achiever Award goes to Pearl Pathway’s CEO and President
On June 9th, 2015 the Women’s Business Enterprise Council – Great Lakes Indiana gave Diana Caldwell, Pearl Pathways CEO and President, the Outstanding Achiever Award. Two months ago, the WBEC held an event recognizing all women owned enterprising and then today it...
Indiana Chapter of RAPS’ is hosting an event June 23rd
The Regulatory Affairs Professional Society is hosting an event featuring Paul Brooks, Senior VP of BSI. The event is June 23rd and will be discussing the “Update on the Current and Proposed EU Medical Device Regulatory Initiatives”. When: June 23rd, 2015 Time: 5:00pm...
Simple steps to improving clinical trials
This past May 20th was International Clinical Trials Day celebrating the life changing triumphs that result from the efforts accomplished by clinical researchers. Its birth was inaugurated back in 1747 when James Lind pursued a cure for scurvy. BioMed Central...