Accurate, Focused Research on Law, Technology and Knowledge Discovery Since 2002

Daily Archives: June 9, 2020

Legal Issues in COVID-19 Vaccine Development

CRS report via LC – Legal Issues in COVID-19 Vaccine Development, June 8, 2020: “Private companies, universities, and governmental entities are working to develop a vaccine for corona virus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure. Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or improve on existing therapies. Both designations entitle the sponsor to increased communication with FDA regarding the clinical trial design and data collected, as well as rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. In addition, FDA may designate products for priority review…”

Social distanced justice? Courts restart trials, struggle to adapt to COVID-19 precautions

ABC News: “As courts across the country begin to cautiously resume in-person hearings through the COVID-19 pandemic, judges are confronting a vexing challenge: how to safely convene jury trials at a time when health officials continue to caution against public gatherings. With no real federal guidance or uniform system governing the nation’s vast judiciary, current… Continue Reading

Congress and Police Reform: Current Law and Recent Proposals

CRS report via LC – Congress and Police Reform: Current Law and Recent Proposals, Updated June 9, 2020: “In May and June 2020, protests erupted nationwide after the publication of video footage of a Minneapolis police officer pressing his knee into the neck of George Floyd, leading to his death. That incident and its aftermath… Continue Reading

‘Morally Impossible’: Some Advertisers Take a Timeout From Facebook

The New York Times – “Ever since Mark Zuckerberg defended the platform’s hands-off policy toward posts by President Trump that contained misinformation or promoted violence, some companies are staying away…Unlike Twitter and Snap, which have toughened their stances against Mr. Trump’s online statements that contain misinformation or promote violence, Facebook has held firm on its… Continue Reading

COVID-19 Nursing Home Dataset

CMS – “The Nursing Home COVID-19 Public File includes data reported by nursing homes to the CDC’s National Healthcare Safety Network (NHSN) system COVID-19 Long Term Care Facility Module, including Resident Impact, Facility Capacity, Staff & Personnel, and Supplies & Personal Protective Equipment, and Ventilator Capacity and Supplies Data Elements. For a full list of… Continue Reading

The activist dismantling racist police algorithms

MIT Technology Review – “Hamid Khan has been a community organizer in Los Angeles for over 35 years, with a consistent focus on police violence and human rights. He talked to us on April 3, 2020, for a forthcoming podcast episode about artificial intelligence and policing. As the world turns its attention to police brutality… Continue Reading

We Mapped Where Customs and Border Protection Drones Are Flying in the U.S. and Beyond

Gizmodo: “Over nearly a decade since that standoff, the details of CBP’s drone operations have been vague. Previous reporting and public documents suggest that the agency operates a fleet of 10 Predator drones that are legally permitted to patrol within 100 air miles of the border—CBP also asserts the power to do so within 100… Continue Reading