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Daily Archives: June 2, 2020

Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines

CRS report via LC – Testing, Testing, (Phase) 1-2-3: Legal Considerations for Clinical Trials of Potential COVID-19 Vaccines, June 1, 2020: “In the race to develop a Coronavirus Disease 2019 (COVID-19) vaccine, several pharmaceutical companies, governments, and educational institutions around the world have begun testing their potential COVID-19 vaccines in clinical trials. Clinical trials are used to assess whether a new pharmaceutical product, such as a vaccine, is safe for humans and effective in achieving its intended purpose. Companies must generally test new pharmaceutical products on humans through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to market the product. But using human subjects to test these novel products exposes them to unknown health and safety risks, raising ethical considerations for FDA and for the sponsors and Institutional Review Boards (IRBs) overseeing the investigations. These stakeholders—sponsors, IRBs, and FDA—aim to balance the need to ensure that the product is safe and effective against the desire to bring the product to market quickly, tensions that are heightened during a worldwide pandemic. Existing law requires FDA and IRBs to weigh these considerations when evaluating proposed clinical trial designs for COVID-19 vaccines. This Sidebar describes the legal and regulatory framework that governs clinical trials for pharmaceutical products, such as vaccines, and some avenues researchers and Congress may consider for accelerating that process during the COVID-19 pandemic. (For ease of reference, this Sidebar uses the term drugs includes both traditional drugs and biological products, including vaccines.)…”

Senators propose COVID-19 contact-tracing privacy bill

CNet – The bipartisan effort aims to protect users as technology is used to trace the spread of the novel coronavirus. “A group of US senators on Monday introduced a bill to regulate contact-tracing apps, aiming to protect user privacy as technology is used to track the spread of the novel coronavirus.  The proposal is… Continue Reading

Google faces $5 billion lawsuit in U.S. for tracking ‘private’ internet use

Reuters: “Google was sued on Tuesday in a proposed class action accusing the internet search company of illegally invading the privacy of millions of users by pervasively tracking their internet use through browsers set in “private” mode. The lawsuit seeks at least $5 billion, accusing the Alphabet Inc unit of surreptitiously collecting information about what… Continue Reading

USPS Provides Recommendations for Successful 2020 Election Mail Season

“Today the U.S. Postal Service (USPS) released a letter that is being sent to local and state election officials and state party officials around the country. This letter highlights key aspects of Election Mail delivery processes — and ways to help educate the public on what to expect when using the mail to vote.  The… Continue Reading

NPAP Condemns Police’s Use of Overwhelming Force Against Protesters

“The National Police Accountability Project (NPAP) condemns the use of overwhelming force by law enforcement to block legitimate protest against the racist and unconstitutional use of deadly force against Black Americans and other minorities. We denounce the president of the United States for using armed military units to clear the streets of peaceful demonstrators in… Continue Reading

AG Barr on DC protests – expect increased law enforcement in the region

@ABCNewsPolitics: “Attorney General Bill Barr releases statement on protests in Washington, D.C., saying, “there will be even greater law enforcement resources and support in the region tonight…” Meanwhile our area remains under surveillance overhead by military helicopters, planes and drones. Via Wired – The Feds Are Now Using ‘Stingrays’ in Planes to Spy on Our… Continue Reading

DEA Has Permission To Investigate People Protesting George Floyd’s Death

“The Drug Enforcement Administration has been granted sweeping new authority to “conduct covert surveillance” and collect intelligence on people participating in protests over the police killing of George Floyd, according to a two-page memorandum obtained by BuzzFeed News. Floyd’s death “has spawned widespread protests across the nation, which, in some instances, have included violence and… Continue Reading

What Happens to Powell’s Books When You Can’t Browse the Aisles?

The New York Times – The enormous independent bookstore in Portland, Ore., became an unlikely tourist attraction. Now that it’s shut, Emily Powell, the chief executive, is having to rethink the books business. “Powell’s Books was selling books online before existed. Over the years, its flagship store grew to occupy a full city block… Continue Reading