Pearl IRB will attend and exhibit at the upcoming Association of Clinical Research Professionals (ACRP) 2019 conference. The event takes place April 12 – 15 in Nashville, Tennessee. Stop by our booth (#549) to meet our team! About ACRP 2019 ACRP 2019 brings the...
Kind of like finishing the Indy 500 on a yellow flag – with the government shut down and no one available to postpone the changes, it appears the new Common Rule revisions will go into effect January 21st. After the 21st, the IRB will ask you to update your study...
Updates to the Common Rule, the principal rule which regulates human subjects research, are scheduled to go into effect this month on January 21, 2019 (after several delays). Studies approved or altered after January 21 will be governed by the new rule. If necessary,...
The United States Food and Drug Administration (FDA) set a new record for generic drug approvals in October 2018, RAPS reports. The new number to beat is 128. The 128-total comprised of 110 approvals and 18 tentative approvals, and also included 23 first generic drug...
Are you developing a biopharmaceutical, device, or diagnostic that requires FDA approval? If so, the pathway towards regulatory approval often commences with a Pre-IND or Pre-Submission meeting. Purdue Foundry will host Robert Seevers, PhD, a Senior Advisor here at...
