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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 | FDA
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-procedural-notice-potential-plans-conduct-research-about-use-healthy-symbols

May 6th, 2021 - For Immediate Release: May 06, 2021 The following quote is attributed to Conrad Choiniere, Ph.D., director of the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition "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 symbo...

UK COVID-19 Update: Strong Protection from Pfizer Jab and Vaccine Confidence Remains High
https://www.medscape.com/viewarticle/950654

May 5th, 2021 - These are the UK coronavirus stories you need to know about today. A supplementary analysis showed that a single dose of the vaccine was associated with moderate protection against infection, hospitalisation, and death, emphasising the importance of fully vaccinating adults, the researchers said. They acknowledged remaining uncertainties about the duration of immunity, and the possible emergenc...

CVST With AZ COVID Vaccine: 1 in 40,000 'More Reliable' Estimate
https://www.medscape.com/viewarticle/950646

May 5th, 2021 - Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center. A new study that systematically monitored rates of vascular and thromboembolic events in people receiving the AstraZeneca COVID-19 vaccine has found it to be associated with a rate of cerebral venous sinus thrombosis (CVST) of 1 in 40,000. "Early on, we thought CVST was a very rare occurrence — ...

Would You Get a Vaccine Passport to Travel?
https://www.medscape.com/viewarticle/950622

May 5th, 2021 - As some companies, venues, and governments form plans to implement "vaccine passports" (and others pledge to prohibit them), individuals may soon face choices about whether to get such proof of vaccination to travel or participate in certain events. What will you do? You must Log In to answer this question

Endoscopic Device Could Expand Treatment for GERD, Reduce PPI Use
https://www.medscape.com/viewarticle/950689

May 5th, 2021 - In patients with proton pump inhibitor (PPI)–dependent gastroesophageal reflux disease (GERD), a procedure known as endoscopic full-thickness plication (EFTP) — performed with the novel GERD-X device — improved both symptoms and quality of life, compared with a sham procedure. It also had few side effects and a short procedure time, according to a new randomized, controlled trial. "It seems lik...

Infective Endocarditis With Stroke After TAVR Has 'Dismal' Prognosis
https://www.medscape.com/viewarticle/950702

May 5th, 2021 - Patients who suffer a stroke during hospitalization for infective endocarditis (IE) after transcatheter aortic valve replacement (TAVR) have a dismal prognosis, with more than half dying during the index hospitalization and two thirds within the first year, a new study shows. The study — the first to evaluate stroke as an IE-related complication following TAVR in a large multicenter cohort — is...

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...

With RA in Remission, Tapering of Conventional DMARDs May Lead to Disease Flares for Some Patients
https://www.medscape.com/viewarticle/950455

May 4th, 2021 - NEW YORK (Reuters Health) - In patients with rheumatoid arthritis (RA) in remission taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), cutting the drug dose in half could lead to more disease flares, according to a randomized controlled trial. Sustained remission is now achievable for RA patients receiving csDMARDs, but how to best manage patients in clinical remiss...

When to Refer Patients With New Memory Loss
https://www.medscape.com/viewarticle/950534

May 4th, 2021 - Asking a patient who has concerns about memory loss particular questions can guide referral decisions, according to new research. Initial questions should zero in on what the patient is forgetting, said Megan Richie, MD, a neurohospitalist at the University of California, San Francisco, who spoke to a virtual audience at the American College of Physicians (ACP) Internal Medicine Meeting. Is the...

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...

Delays a Major Cause of Transfusion-related Deaths
https://www.medscape.com/viewarticle/950553

May 4th, 2021 - Transfusion-related circulatory overload (TACO) remains the most common cause of transfusion-related death, although deaths due to delays are increasing year-on-year, shows an analysis of reports to the UK’s transfusion safety body. "Communication is a major, major issue" when it comes to delays, which account for over one in four deaths, explained lead author Simon Carter-Graham, clinical inci...

Nutritional Support May Be Lifesaving in Heart Failure
https://www.medscape.com/viewarticle/950599

May 4th, 2021 - Personalized nutritional support for adults hospitalized with chronic heart failure and deemed to be at high nutritional risk reduced the risk of dying or suffering adverse cardiovascular events compared with standard hospital food, new research indicates. The Swiss EFFORT trial focused on patients with chronic heart failure and high risk of malnutrition defined by low body mass index (BMI), we...

Therapeutic Drug Monitoring Has Little Value During Infliximab Induction
https://www.medscape.com/viewarticle/950456

May 4th, 2021 - NEW YORK (Reuters Health) - Results of a randomized controlled trial do not support routine use of proactive therapeutic drug monitoring (TDM) during infliximab induction for improving disease remission rates in patients with rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. Proactive TDM tailors biologic therapy to individual patients by measuring serum drug le...

Corticosteroid Bursts May Increase GI Bleeding, Sepsis Risk in Children
https://www.medscape.com/viewarticle/950567

May 4th, 2021 - Oral corticosteroid bursts are associated with an increased risk of gastrointestinal bleeding, sepsis, and pneumonia during the month after treatment initiation, according to a nationwide cohort study of children in Taiwan. The adverse events are rare, and the risk attenuates in subsequent months, the analysis shows. Still, the study "provides evidence that corticosteroid bursts are not innocuo...

Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate | FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-sterile-water-injection-usp-due-potential

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial Company Announcement Hospira, Inc., a P...

Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% Lidocaine HCl Injection, USP Due to Mislabeling | FDA
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-05-bupivacaine-hydrochloride-injection-usp-and

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to mislabeling Company Name: Hospira, Inc. Brand Name: Brand Name(s) Hospira, Inc. Product Description: Product Description 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL Company Announcement Hosp...

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 ...

Superior Survival With Sintilimab in Squamous NSCLC
https://www.medscape.com/viewarticle/950480

May 3rd, 2021 - Second-line treatment with sintilimab improved survival, when compared with docetaxel, in patients with advanced/metastatic squamous non–small cell lung cancer (sqNSCLC) in a phase 3 trial. Sintilimab improved both overall survival (OS) and progression-free survival (PFS), according to Yuankai Shi, MD, of the Chinese Academy of Medical Sciences & Peking Union Medical College in Beijing. Shi pre...

States Announce Reopenings, End of COVID Restrictions
https://www.medscape.com/viewarticle/950496

May 3rd, 2021 - As COVID-19 cases fall and vaccination numbers rise in the U.S., governors are making plans to reopen businesses, resume public transportation, and lift public health restrictions. In Florida, Gov. Ron DeSantis suspended all of the remaining COVID-19 restrictions on Monday, according to The Hill California also updated its mask guidance on Monday to allow those who are fully vaccinated to remov...