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 technology. He...
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...
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 updates are to...
The Final Rule to update the current regulations at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (the Common Rule) was published by the U.S. Department of Health and Human Services (DHHS) on 19 January 2017 in the...
A new draft guidance issued by the U.S. Food and Drug Administration (FDA) provides advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials for cancer drugs and biologics. The draft guidance, issued in August 2018, describes the use...
In clinical labs, a persistent need for lab information management software exists. However, up until recently most companies would purchase many different types of software systems and then customize it to meet the laboratory’s needs. In order to customize the...
