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FDA wants to regulate thousands of lab tests that have long skirted oversight

Published Tue, 05 Nov 2024 16:38:57 GMT

WASHINGTON (AP) — The Food and Drug Administration on Friday laid out a proposal to begin regulating laboratory medical tests, a multibillion-dollar industry that the agency says poses a growing risk to patients because of potentially inaccurate results.The proposed rule would end decades of regulatory ambiguity and formally bring thousands of tests performed in large laboratories under FDA oversight. FDA Commissioner Robert Califf said the change will help ensure tests used to diagnose cancer, heart disease and many other conditions are safe, accurate and reliable.“A growing number of clinical diagnostic tests are being offered as laboratory-developed tests without assurance that they work,” Califf said in a statement. He added that the agency has long worried that many tests offered by laboratories are not as accurate or reliable as those that undergo FDA review.Here’s a look at the history and background of the testing issue:What are laboratory-developed tests?Most Am...

Judge greenlights class action against Bausch Health on Cold-FX products

Published Tue, 05 Nov 2024 16:38:57 GMT

TORONTO — An Ontario Superior Court judge has certified a class-action lawsuit against Bausch Health Companies Inc. that alleges false advertising for some of the pharmaceutical firm’s cold remedies.The lawsuit states that Bausch, formerly known as Valeant Pharmaceuticals, made false or misleading ad claims to consumers around five of its Cold-FX products.Filed in 2019, the suit notes that packaging and social media profiles for the products include statements such as “clinically proven” and “proven by science” to help reduce cold and flu symptoms.Toronto-based law firm Tyr LLP says those claims form the basis of allegations that Bausch breached provincial consumer protection laws as well as the federal Competition Act and the Food and Drugs Act.The class action includes anyone in Canada who bought one of the five Cold-FX products in the nearly seven years between 2017 and this week.Bausch denies it has broken the law or made any false or deceptive stat...

At the New York Film Festival, a sluggish fall movie season seeks a higher gear

Published Tue, 05 Nov 2024 16:38:57 GMT

NEW YORK (AP) — Momentum has lately been hard to come by at the movies. The big trio of fall film festivals — Venice, Telluride, Toronto — came and went without the usual amount of buzz. With actors on strike, red carpets have been mostly bare. It’s almost like since the heady highs of “Barbenheimer,” the movies have been sleeping off a hangover. When the 61st New York Film Festival opens Friday night, things may finally be stirring once again. There is movement on the labor stoppage. Screenwriters are poised to ratify a new contract after nearly five months of striking. The actors union, SAG-AFTRA, is to recommence talks with the studios next week. At the same time, the New York Film Festival will play host to easily the best assemblage of movies this year. Each major festival has had their highlights, but for the next two weeks, a large share of the fall’s best films will screen at Lincoln Center. “The unsettled state of the industry is an unavoidable talking point the...

Man attempts to sexually assault woman after demanding entry into her apartment: CPD

Published Tue, 05 Nov 2024 16:38:57 GMT

CHICAGO — Police are investigating after an attempted sexual assault of a woman on the city's Far South Side.The incident happened around 4:30 a.m. Friday on the 9000 block of South Loomis. According to police, the 41-year-old woman was approached by a 39-year-old man who demanded her to open her apartment door.After entering her apartment, the man then attempted to sexually assault and batter the woman. The man then fled the scene in an unknown direction. Girl, 10, shot by stray bullet that entered her home on South Side No injuries were reported.No one is in custody. Area Two Detectives are investigating.

How the Cubs can still make the playoffs in the final weekend

Published Tue, 05 Nov 2024 16:38:57 GMT

ATLANTA — The Cubs' path to the playoffs got harder and a little weirder on Thursday thanks to events in Atlanta and New York.Now the club is going to need a fair amount of help to make the postseason, and may have to wait until Monday to figure out their playoff fate. After losing to the Braves 5-3 at Truist Field on Thursday night, the Cubs now sit a half-game behind the Marlins for the last National League Wild Card spot. Meanwhile, Miami's game with the Mets in New York was suspended due to rain in the ninth inning Thursday after the Marlins had just taken the lead.Because of that, the suspended game would be completed on Monday at Citi Field at 12:10 p.m. if the result could decide the Wild Card.After being swept in Atlanta, the Cubs will face the Brewers for three games in their final series of the season at Miller Park in Milwaukee. Meanwhile, the Marlins are in Pittsburgh for three games against the Pirates. So what has to happen for the Cubs to make the playoffs?Since they ...

Biden administration announces next steps for student debt relief

Published Tue, 05 Nov 2024 16:38:57 GMT

(The Hill) - The Biden administration announced its next moves toward student loan forgiveness on Friday, pointing toward a more narrowed effort so far than the mass debt relief it previously offered. The Department of Education announced months ago it is going through the negotiated rulemaking process under the Higher Education Act to try to enact more student loan relief. The department has released its “initial set of policy considerations” for the new plan, focusing on “student loan borrowers in need.”There are five groups the administration is looking at for its new debt relief: borrowers who entered repayment decades ago, whose balances are greater than what they originally owed, who are eligible for relief under specific programs but didn’t apply, those under financial hardship and those who went through programs that didn’t give financial value. “The Biden-Harris Administration has taken unprecedented action to fix the broken student loan system and deliver record ...

AFD finds body while responding to west Austin grass fire

Published Tue, 05 Nov 2024 16:38:57 GMT

AUSTIN (KXAN) — A body was found in west Austin in an area where a grass fire burned Friday morning.The Austin Fire Department said firefighters found the body while responding to a grass fire in the 3600 block of Mesa Drive, which is in the Northwest Hills area. -->AFD responded to the scene shortly after 5 a.m.Arson investigators are at the scene. They have not determined if the body of the person found is connected to the start of the fire.

Wild sign veteran wing Mats Zuccarello to two-year extension

Published Tue, 05 Nov 2024 16:38:57 GMT

The Wild have signed winger Mats Zuccarello to a two-year, $8.25 million contract extension, general manager Bill Guerin said Friday.Zuccarello, 36, signed a five-year free agent deal that expires this season in 2019 and has become a fixture on the Wild’s top line with winger Kirill Kaprizov and center Ryan Hartman.He scored 22 goals among 67 points last season and has averaged 15 goals and 64 assists in four seasons with Minnesota. Nearly as important has been his mentorship of Kaprizov, the young Russian wing who has blossomed into one of the NHL’s best scorers since joining the team in 2020-21.Discussing the Wild’s desire to sign Kaprizov to a long-term deal, owner Craig Leipold said Thursday that Zuccarello’s presence on the roster will likely be a factor in getting that deal inked.“Their chemistry is so good, they work hard at it, they trust each other,” Leipold said. “I wouldn’t be honest if I didn’t tell you that’s an important part of why (Zuccarello) is important to our tea...

Galway's 'Skeleton House' hosting first haunted hayride

Published Tue, 05 Nov 2024 16:38:57 GMT

GALWAY, N.Y. (NEWS10) -- If you're driving through Galway this spooky season, make sure to check out the skeleton displays outside the house across the street from the Galway Public Library. Known by the community as the "Skeleton House," owner Jessica Fragnoli said this comes from her love of Halloween. Get the latest news, weather, sports and entertainment delivered right to your inbox! Fragnoli has lived in Galway for three years. Around September 1, usually to correspond with school starting, Fragnoli puts out the skeleton displays depicting scenes from movies and other pop culture references.She changes the scenes weekly. Previous displays featured "E.T. the Extra-Terrestrial," Marie Antoinette, and "Wayne's World. " This week's display features "American Psycho." Fragnoli said people often stop in front of her house at 2119 East Street to take photos.The Skeleton House (photo courtesy: Jessica Fragnoli)The Skeleton House (photo courtesy: Jessica Fragnoli)The Skeleton House (...

Hyde Collection brings Met opera to Glens Falls

Published Tue, 05 Nov 2024 16:38:57 GMT

GLENS FALLS, N.Y. (NEWS10) - In the coming months, the Metropolitan Opera House is coming to the Hyde Collection - digitally. "The Met: Live in HD" is broadcasting at the Warren Street museum starting this October, with opera and more running until next May. Get the latest news, weather, sports and entertainment delivered right to your inbox! The series includes a opera based on the life of Malcolm X, a performance of "The Magic Flute," and more - all simulcast from the stage of the Met. In cooperation with the Sembrich Museum in Bolton Landing, several opera events will feature a 15-minute preview discussion with artists and musicians. Once the live show gets started, artists involved with the Met give behind-the-scenes glimpses and live interviews with the people who make shows possible.“We are so excited to offer the 2023-24 season of "The Met: Live in HD," said Hyde Collection Education and Engagement Curator Katelyn Foley. "We have been working on this new offering for severa...