An initiative spearheaded by the Centers for Disease Control’s Office of Advanced Molecular Detection (OAMD) seeks to bring the SARS-CoV-2 sequencing work of private and academic labs into the public sphere.

Based on its first randomized comparison to standard ICDs, the subcutaneous-lead ICD 'should be considered in all patients who need an ICD who do not have a pacing indication,' researchers said.
Medscape Medical News

(MedPage Today) -- Note that some links may require registration or subscription. The Trump administration has decided not to implement a CDC-backed plan to reopen America, including step-by-step advice for mass transit, day care facilities, schools...

(MedPage Today) -- Subcutaneous implantable cardioverter defibrillators (S-ICDs) performed on par with conventional transvenous ICDs (TV-ICDs) in the first head-to-head randomized trial. The overall primary composite endpoint of inappropriate...

The CDC has added six new symptoms to its list of signs that a person has been infected with the new coronavirus, including chills and loss of sense of smell.

Health news and commentary from around the Web gathered by the ALLMedPage Today staff

Members of the Energy and Commerce Committee’s Health and Oversight and Investigations subcommittees today held a bipartisan teleconference forum with Centers for Disease Control and Prevention (CDC) Principal Deputy Director Anne Schuchat, M.D., to discuss racial disparities in health outcomes for COVID-19 patients. Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Health Subcommittee Ranking Member Michael C. Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Oversight and Investigations Subcommittee Ranking Member Brett Guthrie (R-KY) released a joint statement following the call: “Today, bipartisan members of our two subcommittees discussed the deeply troubling racial disparities in health outcomes for COVID-19 patients with CDC’s Principal Deputy Director Schuchat.  During the call, members received an update on CDC’s COVID-19 response, current data collection efforts, and reiterated the need for more accurate and timely demographic data.  “Congress stands ready to work with the CDC to secure comprehensive demographic data to help us direct resources and support to close this gap in these health outcomes.” ###

The group will work to rapidly develop guidance on standardizing COVID-19 research data, with the help of several participating member companies.

The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 1,248,040 cases of the new coronavirus, an increase of 28,974 cases from its previous count, and said that the number of deaths had risen by 2,180 to 75,477.

A federal grand jury in San Francisco returned an indictment against two former executives from Chunghwa Picture Tubes Ltd. (Chunghwa) and one former executive from LG Display Co. Ltd. (LG) for their participation in a global conspiracy to fix prices of Thin Film Transistor-Liquid Crystal Display (TFT-LCD) panels.

Japanese electronics manufacturer Hitachi Displays Ltd., agreed to plead guilty and pay a $31 million fine for its role in a conspiracy to fix prices in the sale of Thin Film Transistor-Liquid Crystal Display panels (TFT-LCD) sold to Dell Inc.

A federal grand jury in San Francisco returned an indictment today charging an executive at Hitachi Displays Ltd. with participating in a global conspiracy to fix the prices of Thin Film Transistor-Liquid Crystal Display (TFT-LCD) panels sold to Dell Inc.

A high-level Korean executive from LG Display Co. Ltd. (LG) has agreed to plead guilty and serve a year in jail in the United States for participating in a global conspiracy to fix prices in the sale of Thin Film Transistor-Liquid Crystal Display (TFT-LCD) panels.

Japanese electronics manufacturer Epson Imaging Devices Corporation (Epson) agreed to plead guilty and pay a $26 million criminal fine for its role in a conspiracy to fix prices in the sale of Thin Film Transistor-Liquid Crystal Display panels (TFT-LCD) sold to Motorola Inc.

Deputy Attorney General David W. Ogden, along with federal and local officials today officially unveiled the new Organized Crime Drug Enforcement Task Force (OCDETF) Strike Force site in Phoenix.

The OCDETF Program -- now in its 27th year -- is a model of interagency coordination, innovation, and teamwork, and is the cornerstone of the Justice Department’s anti-cartel strategy.

Companies directly affected by the LCD price-fixing conspiracy are some of the largest computer and television manufacturers in the world, including Apple, Dell and HP.

A federal grand jury in San Francisco returned a superseding indictment against AU Optronics Corporation, its Houston-based American subsidiary and six of its executives for participating in a conspiracy to fix prices of TFT-LCD panels.

A Taiwan thin-film transistor-liquid crystal display (TFT-LCD) panel producer and seller has agreed to plead guilty and to pay a $30 million criminal fine for its role in a global conspiracy to fix the prices of TFT-LCD panels.

According to a one-count felony charge filed in U.S. District Court in San Francisco, Wen-Hung “Amigo” Huang conspired with others to suppress and eliminate competition by fixing the prices of TFT-LCD panels.

A former executive from Chi Mei Optoelectronics Corporation has agreed to plead guilty and to serve jail time in the United States for participating in a global conspiracy to fix the price of thin-film transistor-liquid crystal display panels.

Mamadou Sadio Barry and Moussa Baradji were convicted today for their involvement in a counterfeit DVD and CD ring.

A federal grand jury in San Francisco returned an indictment against a former executive of a Taiwan thin-film transistor liquid crystal display (TFT-LCD) producer for participating in a global conspiracy to fix prices of TFT-LCD panels.

A former executive from HannStar Display Corporation has agreed to plead guilty and to serve jail time in the United States for participating in a global conspiracy to fix the price of thin-film transistor liquid crystal display (TFT-LCD) panels.

CDI Corporation has agreed to pay the United States $1.95 million to resolve allegations in a lawsuit brought under the False Claims Act that CDI wrongfully charged labor costs to work orders under military aircraft engine contracts for The General Electric Company.

A federal grand jury in San Francisco returned an indictment against the current president of HannStar Display Corporation for his participation in a global conspiracy to fix prices of thin-film transistor liquid crystal display (TFT-LCD) panels.

Four individuals have been sentenced this week in Atlanta by U.S. District Judge William S. Duffey Jr., for their involvement in a counterfeit DVD and CD ring.

Ibrahim Diallo, 27, of Atlanta, was sentenced to 38 months in prison today by U.S. District Judge William S. Duffey Jr., in Atlanta for his involvement in a counterfeit DVD and CD ring.

Charles Ndhlovu was convicted today for his participation in a counterfeit DVD and CD ring.

Charles Ndhlovu, 34, was sentenced on Dec. 12, 2011, by U.S. District Judge William S. Duffey Jr. to 51 months in prison and Scott Ahn, 42, was sentenced yesterday by Judge Duffey to 19 months in prison.

A Beverly Hills, Calif.,-based financial products and services firm, and its founder and owner pleaded guilty today in the Southern District of New York for their participation in bid-rigging and fraud conspiracies related to contracts for the investment of municipal bond proceeds and other related municipal finance contracts.

An executive and a former executive of Rubin/Chambers, Dunhill Insurance Services, also known as CDR Financial Products, pleaded guilty today in the Southern District of New York for their participation in bid-rigging and fraud conspiracies related to contracts for the investment of municipal bond proceeds and other related municipal finance contracts.

A federal jury in San Francisco today convicted the largest Taiwan liquid crystal display producer, its subsidiary and their two former executives for their participation in a conspiracy to fix the prices of thin-film transistor-liquid crystal display panels sold worldwide.

AU Optronics Corporation, a Taiwan-based liquid crystal display (LCD) producer, was sentenced today in U.S. District Court in San Francisco to pay a $500 million criminal fine for its participation in a five-year conspiracy to fix the prices of thin-film transistor LCD panels sold worldwide.

Following a three-week trial, a federal jury in San Francisco today convicted an executive of the largest Taiwan liquid crystal display (LCD) producer for his participation in a worldwide conspiracy to fix the prices of thin-film transistor-liquid crystal display (TFT-LCD) panels sold worldwide.

CDW-Government LLC has agreed to pay $5.66 million to resolve allegations that it submitted false claims in connection with a U.S. General Services Administration (GSA) contract.

An executive of AU Optronics Corp., a Taiwan-based liquid crystal display (LCD) producer, was sentenced today in U.S. District Court in San Francisco for his participation in a worldwide thin-film transistor-liquid crystal display (TFT-LCD) price-fixing conspiracy.

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

J&J agrees a manufacturing partnership with Emergent, as it looks to hit its target of one billion doses.

UPDATE: The guidance mentioned below was released. Here's the link.

The FDA has released the CDER Guidance Agenda. For ad-promo professionals, the most most significant item is the inclusion of an item labeled:

• Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products--Questions and Answers 

The Maximus call center was accused by a whistleblower of failing to practice what it hired workers to preach.

Yokogawa Electric Corporation (TOKYO: 6841) announces that it has made it onto CDP's Water Security A List and Supplier Engagement Leader Board. The A listing is for the company's sustainable water management practices and disclosure of information on these activities, and the selection to the leader board is for the company's leadership in engaging with its suppliers around the world to reduce carbon emissions and combat global warming.