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FDA draft guidance aims to expedite first-in-human clinical trials for oncology drugs and biologics
A new draft guidance issued by the U.S. Food and Drug Administration (FDA) provides advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials for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 The draft guidance, issued in August 2018,...
Clinical labs experience increased demand for data management solutions
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...
Virus-free CRISPR could lead to more precise gene editing for T-cell therapies
A team from the University of California, San Francisco, created a new electroporation-based CRISPR-Cas9 method, which eliminates viruses from the gene editing process and lays the groundwork for “safer, more precise and more efficient editing for CAR-T...
New Draft Guidance on Gene Therapy
On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming...
Revisions to the Federal Policy for the Protection of Human Subjects (Common Rule) have been delayed 6 months
The Department of Health and Human Services (DHHS) and other federal departments and agencies announced that there will be an additional six-month delay in the general compliance date for changes made to the Federal Policy for the Protection of Human...