Page 8 - Common Rule News Today

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required...

Exhibit 99.1 Risk Factors The following risk factors should be carefully considered together with all of the other information in our annual and quarterly... | October 21, 2021

On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill...

Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and...

Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as "right-to-try." Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures.

pace of reforms in Bulgaria is not as fast as we would like. This is what the Vice-President of the European Commission and Commissioner for Justice Věra Jourová said in an interview with Mediapool. She stresses that Bulgaria has built all the necessary institutions to fight corruption, but the Bulgarian citizens and the EC are still waiting to see the results.  Ms. Jourová, Bulgaria continues to be the country with the least freedom of the media in the EU and ranks 112th in the ranking ...

Ethical Issues to Consider in Developing, Evaluating, and Conducting Research Post-Disaster Disasters, whether unintentional acts of nature or human-made, can have profound effects on those who experience them. Although the physical dangers inherent in disasters are obvious, such events, including terrorism and bioterrorism, are a grave threat to mental health as well. This document offers guidance to investigators, Institutional Review Board (IRB) representatives, public health officials, loca...

Share In today’s world, data is power. Healthcare providers have massive amounts of rich health data at their fingertips. Yet historically, third-party vendors to healthcare providers often have derived financial benefits from secondary use of this data through aggregating and brokering de-identified data to downstream customers. That is beginning to change as healthcare providers are taking back control of their data assets. Truveta, Inc., a new startup led by 14 of the largest health s...

No Yes – private plaintiffs can seek the greater of actual damages or $500 for violations under the VCDPA, and for willful actions, treble damages or $1,000, whichever is greater. Yes (limited) – private plaintiffs can seek damages of not less than $100 and not more than $750, whichever is greater, if their non-encrypted personal information or email address (together with information that would allow account access) is subject to unauthorized access due to a business’ failure to implemen...

02.10.21 -- AI And Machine Learning Prepare Pharma For The Data Onslaught     With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-gene...