Blog
The 5 biggest changes coming for researchers under the Revised Common Rule
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 world’s first gene-edited babies claim, 8 days later
In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9...
FDA sets new record for generic drug approvals in October
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...
FDA In Your Future? Robert Seevers will lead Purdue Foundry event on November 8
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...
FDA releases new guidance for sponsors, investigators, and IRBs ahead of the revised Common Rule
On January 18, 2017, the Common Rule (45 CFR 46, Subpart A), which sets forth requirements for the protection of human subjects involved in research conducted or supported by HHS, was updated for the first time since being issued. The main goals of the...