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FDA In Brief: FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-procedural-notice-potential-plans-conduct-research-about-use-healthy-symbols
US Food and Drug Administration

May 5th, 2021 - The FDA understands that consumers want healthy choices when it comes to food and nutrition. Today, we are issuing a procedural notice on preliminary consumer research we are planning on the use of symbols on food product labels. The symbol could later be used to convey the nutrient content claim ‘healthy.’

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-outlines-inspection-and-assessment-activities-during-pandemic

May 5th, 2021 - For Immediate Release: May 05, 2021 Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward. “Like most organ...

Checkpoint Inhibitor Skin Side Effects More Common in Women
https://www.medscape.com/viewarticle/950535

May 4th, 2021 - Women had about a twofold higher risk than men of developing dermatologic adverse events while taking immune checkpoint inhibitors for metastatic melanoma in a review of 235 patients at Dana Farber Cancer Center, Boston, Massachusetts. Overall, 62. 4% of the 93 women in the review and 48 "This suggests that factors beyond sex hormones are likely contributory" to the difference in risk between m...

Ohio Surgeon Who Wrote His Own Colorful Obituary Dead at 48
https://www.medscape.com/viewarticle/950540

May 4th, 2021 - The family of Ohio surgeon Thomas Lee Flanigan, 48, who died last week, made public the obituary he wrote himself, self-eulogizing his "shocking and unexpected, yet fabulous, exit." Flanigan, who referred to himself as the "Ginger God of Surgery and Shenanigans," wrote, "Yes, I have joined the likes of Princess Diana, John Belushi, and Steve Irwin the Crocodile Hunter in leaving while still at ...

Progress Stalling on Malaria Elimination
https://www.medscape.com/viewarticle/950546

May 4th, 2021 - In its final report on the E-2020 initiative, the World Health Organization (WHO) touted its progress on its goal of eliminating malaria throughout the world. But critics are charging that progress has stalled. The E-2020 initiative supported the efforts of twenty-one countries in eliminating malaria. In a remarkable achievement, especially during the COVID-19 pandemic, eight E-2020 member coun...

Novel Drug Offers Rapid Relief From Agitation in Serious Mental Illness
https://www.medscape.com/viewarticle/950613

May 4th, 2021 - An investigational, orally dissolving film formulation of dexmedetomidine (BXCL501, BioXcel Therapeutics) may offer rapid relief from acute agitation related to schizophrenia or bipolar disorder (BD), results of two phase 3, randomized, placebo-controlled trials show. Dr Leslie Citrome For both disorders, BXCL501 showed "superiority over placebo" by meeting the primary endpoint of reduction of ...

India Virus Variant Identified in Two Southeast Iowa People
https://www.medscape.com/viewarticle/950600

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. DES MOINES, Iowa (AP) — A third coronavirus variant that was first identified in hard-hit India has been uncovered in Iowa, state public health officials said Tuesday. The Iowa Department of Public Health said it has confirmed two cases of the variant, SARS-CoV-2 B.1.617. Health officials are st...

COVID-19 Severity Starts in Normal BMI Range, Especially in Young
https://www.medscape.com/viewarticle/950568

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes and stronger among younger people and Black persons, new research shows. Risk ...

Exclusive: Guidance on Talking to Patients About COVID-19 Vaccines
https://www.medscape.com/viewarticle/950569

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Physicians remain one of the most trusted sources of nonjudgmental information for patients ― including on vaccinations ― and this could come in handy as the daily pace at which people receive COVID-19 vaccines nationwide continues to slow. "Anytime you have a new disease, new procedure, or a ne...

COVID and False Beliefs: How Social Media Exploits Cognitive Bias
https://www.medscape.com/viewarticle/950367

May 4th, 2021 - Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. This transcript has been edited for clarity. Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I'm Dr F. Perry Wilson of the Yale School of Medicine. Medical misinformation is nothing new, but I think we can all agree that the coronavirus pandemic has added fuel to the misinforma...

New Federal Program Reimburses Vaccine Administration Fees for Underinsured Patients
https://www.medscape.com/viewarticle/950544

May 4th, 2021 - A new federal program will cover physicians' costs of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. Physicians will be compensated for vaccine administration at national Medicare rates, which were raised in March. The new COVID-19 Coverage Assistance Fund (CAF), which the Department of Heal...

Montana Tribe Gifts Vaccines to Neighbors Across the Border
https://www.medscape.com/viewarticle/950591

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. BABB, Montana (AP) — On a cloudy spring day, hundreds lined up in their cars on the Canadian side of the border crossing that separates Alberta and Montana. They had driven for hours and camped out in their vehicles in hopes of receiving the season's hottest commodity — a COVID-19 vaccine — from...

Peloton, Feds Agree to Treadmill Recall
https://www.medscape.com/viewarticle/950587

May 4th, 2021 - Exercise giant Peloton has agreed to recall its popular and pricey treadmill after at least one child was killed after becoming caught underneath the machine's belt. Peloton has also agreed to recall its limited-edition Tread, after 18 reports of the touchscreen loosening and six reports of the screen detaching and falling off. No injuries have been reported for the Tread Among the 72 reports o...

COVID Shot in the Arm Not Enough to Keep Pharmacies in Business
https://www.medscape.com/viewarticle/950584

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. Joe Moose, co-owner of Moose Pharmacies in the Charlotte, North Carolina, area, is trying to adapt to the changes dealt by COVID. The chain expanded curbside services, hired additional drivers and tripled home deliveries Most pharmacies, he said, saw a decline in prescriptions last year as custo...

Pharma Company to Pay $12.6M to Settle Kickback Allegations
https://www.medscape.com/viewarticle/950585

May 4th, 2021 - DOVER, Del. (AP) — A Delaware pharmaceutical company has agreed to pay $12.6 million to resolve allegations that it violated the federal False Claims Act by paying kickbacks. Department of Justice officials said in a news release Tuesday that the settlement resolves allegations that Incyte Corp. improperly used an independent foundation to cover the copays of certain people taking the company's...

Biden Wants 70% of the US Vaccinated by July 4
https://www.medscape.com/viewarticle/950597

May 4th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. President Joe Biden has announced new strategies for the national COVID-19 vaccination program as demand for vaccinations drops. He also set a new goal for getting shots into people's arms. "Our goal by July Fourth is to have 70% of adult Americans with at least one shot and 160 million American...

UK COVID-19 Update: 'Significant' Pandemic Burden on Female Staff, Porton Down Investment
https://www.medscape.com/viewarticle/950537

May 4th, 2021 - These are the UK coronavirus stories you need to know about today. 'Significant' Pandemic Burden on Female Staff There was a significant worsening in the physical and mental wellbeing of female health and care workers in England during the pandemic, according to 900 responses to an NHS Confederation poll of male and female staff carried out in February and March. More than 80% of female respond...

Neonatal Nurses, Doctor Help Woman Who Delivered Baby on Plane
https://www.medscape.com/viewarticle/950575

May 4th, 2021 - Three neonatal intensive care nurses and a family physician were in the right place ― on an airliner traveling to Hawaii ― at the right time ― when a woman unexpectedly delivered a baby prematurely on the flight. The medical professionals sprang into action to keep baby Raymond, who came into the world at 29 weeks, healthy until the flight got to Honolulu, according to a news release from Hawai...

Coronavirus (COVID-19) Update: May 4, 2021 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-may-4-2021

May 4th, 2021 - For Immediate Release: May 04, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA Center for Drug Evaluation and Research (CDER) continually monitors our ability to meet user fee commitments. To maintain transparency during the COVID-19 public health emergency, CDER posts periodic updates to the...

FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov | FDA
https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrialsgov

May 4th, 2021 - For Immediate Release: April 28, 2021 Statement From: Statement Author Leadership Role Acting Commissioner of Food and Drugs - Food and Drug Administration Janet Woodcock M.D. Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all ...