Melvin Odoom’s secret attempt to win over Carol Vorderman BEFORE I’m A Celebrity revealedWhen Manmohan Singh had come out sharply against PM Modi during 2024 Lok Sabha pollsEarlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software. FDA’s stated goal for the Guidance is to “to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices,” and it represents notable progress in the Agency’s scramble to keep with – or at least prevent being too far outpaced by – the rapid pace of AI/ML innovation, as used in digital health technology. A. The AI Challenge FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical devices, including, more specifically, medical device modifications . Since the Medical Device Amendments of 1976, FDA has kept a relatively firm grasp on post-market device modifications by requiring manufacturers of legally-marketed devices that originally required 510(k) clearance, De Novo classification, or premarket approval (“PMA”) to submit a supplemental 510(k) notification, De Novo request, and/or approval application for post-market modifications that significantly change or modify the device design, components, method of manufacture, or intended use (i.e., modifications “that could significantly affect the safety or effectiveness of the device, or major changes or modifications in the intended use of the device”).[1] However, regulating AI-DSF, which are designed to constantly self-modify, clearly requires a different approach. FDA has publicly contemplated such an approach since at least 2019, when it published its first discussion paper on the subject.[2] Now, almost six years later, FDA’s first final guidance is here. B. New PCCP Framework The Guidance begins by acknowledging that the development of AI-DSF is an “iterative process” and that its new PCCP framework is designed to provide a “reasonable assurance” of safety and effectiveness. Rather than requiring AI-DSF manufacturers to receive clearance and/or approval for significant modifications after a device is legally marketed, FDA will require that AI-DSF manufacturers include a PCCP with the initial marketing submission (i.e., 510(k) notification, De Novo request, or PMA application). As part of the pre-market review process, FDA will review the PCCP “to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP.” Rather than review each modification as it occurs – which would be impossible to monitor and assess – FDA will review the human-defined objectives (i.e., algorithms) intended to guide the technology’s ongoing self-modifications. The Guidance outlines FDA’s recommendations on the content of a marketing submission for a AI-DSF PCCP, which generally includes: (i) a detailed description of the specific, planned device modifications (i.e., the “Description of Modifications”); (ii) the associated methodology to develop, validate, and implement those modifications in a manner that ensures the continued safety and effectiveness of the device across the intended use populations (i.e., the “Modification Protocol”); and (iii) the assessment of the benefits and risks of the planned modifications and risk mitigations (i.e., the “Impact Assessment”). At a lengthy 49 pages, the Guidance goes into granular detail on each of the three elements of a PCCP (i.e., Description of Modifications, Modification Protocol, and Impact Assessment) but caveats that manufacturers should not rely on the Guidance for a “a complete description of what may be necessary to include in a marketing submission for an AI-DSF” – that is, FDA is careful to clarify that the PCCP is only one piece of a marketing submission for an AI-DSF.[3] The PCCP requirement outlined in the Guidance is broad and applies to both automatic AI-DSF modifications (i.e., modifications that are implemented automatically by software, also known as “continuous learning”), and manual AI-DSF modifications (i.e., modifications involving steps that require human input, action, review, and/or decision-making and therefore are not implemented automatically). Although the Guidance does not explicitly state as much, it is presumed to apply to all future marketing submissions, as it does not include any indication that the requirement would apply retroactively. C. Looking Ahead There is no doubt that the fate of FDA policy, especially policy that is implemented solely through informal guidance (rather than notice-and-comment rulemaking) is a bit up in the air in the face of the incoming administration, which has promised big changes and is centered on a platform of de-regulation. In what may have been an attempt to insulate its new policy from reversal during the upcoming administration, the Guidance goes to great lengths to detail all of the stakeholder input that FDA received and considered in constructing the proposed framework between 2019 and 2024 – a move that we usually see when the Agency issues a final rulemaking, but is less common in informal guidances. However, given that FDA’s first discussion paper (addressing the need to regulate AI-DSF in digital health technology) was published during the previous Trump administration, coupled with the greater push to regulate AI across all industries, this is a rare subset of FDA’s regulatory scheme that could enjoy largely bipartisan support. It remains to be seen whether the upcoming administration will memorialize FDA’s PCCP policy via formal rulemaking, or whether regulators and other key stakeholders will, instead, call on Congress to set the policy for AI-DSF. Either way, the policy outlined in the new Guidance stands, at least for now, and manufacturers of medical devices that utilize AI/ML should begin integrating the preparation of Modification Descriptions, Modification Protocols, and Impact Assessments into their overall product development plans. FOOTNOTES [1] See 21 CFR 807.81(a)(3) . [2] See Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback . [3] See, e.g ., 21 CFR 807.87 , 21 CFR 860.220 , 21 CFR 814.20 .
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The U.S. government on Friday ordered testing of the nation’s milk supply for bird flu to better monitor the spread of the virus in dairy cows. Raw or unpasteurized milk from dairy farms and processors nationwide must be tested on request starting Dec. 16, the Agriculture Department said. Testing will begin in six states — California, Colorado, Michigan, Mississippi, Oregon and Pennsylvania. Officials said the move is aimed at ''containing and ultimately eliminating the virus," known as Type A H5N1, which was detected for the first time in March in U.S. dairy cows. Since then, more than 700 herds have been confirmed to be infected in 15 states. ''This will give farms and farmworkers better confidence in the safety of their animals and ability to protect themselves, and it will put us on a path to quickly controlling and stopping the virus' spread nationwide,'' Agriculture Secretary Tom Vilsack said in a statement. The risk to people from bird flu remains low, health officials said. Pasteurization, or heat treatment, kills the virus in milk, leaving it safe to drink. Veterinarians, farmers, scientists and academics have been calling for nationwide milk testing for months, said Keith Poulsen, director of the Wisconsin Veterinary Diagnostic Laboratory, who led the efforts. ''It's another step in the right direction,'' Poulsen said. ''They're coming around that we need a better handle on it.'' Dairy farmers and processors across the U.S. have been reluctant to test animals or milk for the virus, fearing economic or other repercussions. Jamie Jonker, chief science officer of the National Milk Producers Federation, said the industry supports USDA efforts to eliminate the virus. Under the federal order, dairy farmers and those who handle raw milk intended for pasteurization must provide samples of the milk on request for testing for bird flu. It requires reporting of positive tests to the USDA and it requires herd owners to provide basic information to allow tracing of the disease in cattle. The move follows an April 24 federal order that mandated testing of certain dairy cattle before they could move between states and required reporting of any positive tests. Despite that order, the virus has continued to spread, Poulsen noted. Raw milk from infected cows contains high loads of live virus, testing has shown. At least 58 people in the U.S. have been infected with bird flu, mostly farm workers who became mildly ill after close contact with infected cows, including their milk, or infected poultry. Bird flu has also been spreading among wild birds and a number of other animals. Federal officials continue to warn against drinking raw milk, which can contain a host of germs that make people sick. In California, officials quarantined a farm and halted distribution of milk after bird flu virus was detected in raw milk sold in stores. Raw Farm of Fresno issued a voluntary recall of raw milk and cream produced after Nov. 9. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is solely responsible for all content.
AP Sports SummaryBrief at 5:44 p.m. ESTManmohan Singh symbolised humility to be remembered for his public service Assam leaders
(CNN) — President-elect Donald Trump is expected to offer Kelly Loeffler the job of secretary of the Department of Agriculture, two people familiar with the matter told CNN. He is set to meet with her at Mar-a-Lago Friday afternoon, but as is always the case, nothing is final until Trump announces it. Loeffler, who briefly represented Georgia in the Senate, had fundraised for Trump during the 2024 race and raised several million dollars for his campaign over the summer when she hosted a debate watch party with Republican National Committee Chair Michael Whatley. Several of Trump’s other Cabinet picks — including Sen. Marco Rubio and Rep. Elise Stefanik — were at that party. Loeffler is also co-chairing Trump’s inauguration, as CNN previously reported. The agriculture job will likely be a significant one — especially as Trump’s pick to run the Department of Health and Human Services, Robert F. Kennedy Jr., has promised to assert his influence over the agriculture industry. Loeffler, appointed to the Senate by Georgia Gov. Brian Kemp over the wishes of Trump, lost her seat in a 2021 runoff to Democratic now-Sen. Raphael Warnock. Loeffler was a staunch Trump ally in Congress, saying prior to the violence on January 6, 2021, that she planned to vote against certifying her state’s electoral results in support of Trump’s broader effort to upend Joe Biden’s 2020 election victory. After the US Capitol attack, Loeffler backed off her objection, saying on the Senate floor: “When I arrived in Washington this morning, I fully intended to object to the certification of the electoral votes. However, the events that have transpired today have forced me to reconsider, and I cannot now in good conscience object to the certification of these electors.” In the same speech, Loeffler condemned the violence at the Capitol, calling it “abhorrent.” Loeffler was among the witnesses who appeared before the grand jury as part of Trump’s 2020 election subversion criminal case in Georgia. Before joining the Senate, Loeffler served as an executive at a financial services firm in Atlanta. She was also a co-owner of the WNBA’s Atlanta Dream. She was among the wealthiest lawmakers during her short time in Congress. Her husband, Jeffrey Sprecher, is the CEO of the Intercontinental Exchange. When running for election in 2020, she announced she and her husband were divesting from individual stocks amid sharp criticism over trades she and other lawmakers made ahead of the market downturn caused by the coronavirus. Kemp had appointed Loeffler to fill the seat of Johnny Isakson, who had left the Senate before the end of his term because of health concerns. Trump, however, had pressed the governor to appoint then-Rep. Doug Collins, who then challenged Loeffler for the remainder of Isakson’s term. The two Republicans sought to one-up the other and showcase their loyalty to Trump, moving further and further to the right in a state where Atlanta’s more moderate suburban voters were key. Collins fell short in the November 2020 election, while Loeffler and Warnock advanced to the January 2021 runoff. This year, Trump has selected Collins to lead the Department of Veterans Affairs.The key word for this Fall Festival is 'Share'
Is Technology Worthy of Our Faith?The U.S. played a pivotal role in the withdrawal of a report warning of a pending famine in northern Gaza, according to U.S. officials who spoke with The Associated Press. The report, initially issued by the Famine Early Warning System (FEWS), highlighted the dire conditions in Gaza under Israel's blockade. U.S. Ambassador to Israel Jacob Lew publicly condemned the report, describing it as erroneous and lacking proper context regarding the humanitarian situation in Gaza. Critics have accused the American government of interfering politically with a report intended to provide unbiased information on the crisis. The debate underscores the sensitivity of the situation in Gaza, where Israel continues efforts against Hamas militants. Aid organizations have voiced concerns about the repercussions of blocking food and resources, while the U.S. remains Israel's primary supporter in its military endeavors. (With inputs from agencies.)
Pittsburg prepares for transition as Scales-Preston becomes Contra Costa supervisorMETAIRIE, La. (AP) — Dejounte Murray plans to return to the New Orleans Pelicans ' lineup on Wednesday night for the first time since fracturing his left hand in a season-opening victory over Chicago on Oct. 23. And when Murray takes the court against the Toronto Raptors , his mother will be on his mind. After practice on Tuesday, Murray discussed his impending return and disclosed more details about the previously unspecified “personal matters” that caused him to leave the team during the final days of the preseason. His mother had a stroke, he said. “It was tough to leave and go deal with that. As she got better, she wanted me to come play,” Murray said of his last-minute decision to start against Chicago. He added that his hand injury near the end of that game was God's way of telling him, “‘Nah, you need to stay with your mom.’” “I was more concerned about my mother. That was my priority,” Murray continued. “I wasn’t really worried about my recovery.” Murray's mother has recovered well, he said, while he is “healthy and ready to help this team.” “I’m ready to hoop. Play for my mother — she’s going to be watching," Murray said. “I’m ready to compete, bring that winning spirit.” The Pelicans (4-14) certainly could use the help, having lost 14 of 16 games since opening the season with a pair of victories. Injuries have ravaged the roster. At times, all five starters have been out. Star power forward Zion Williamson has missed 12 games this season — one with an illness and 11 with a hamstring injury. Herb Jones has been sidelined by a shoulder strain and Brandon Ingram's status is in doubt after he sat out practice on Tuesday with calf soreness that also sidelined him during a loss on Monday night at Indiana. But at least two starters — Murray and fellow guard CJ McCollum — are expected to play against the Raptors. “I don’t care how many games we’ve lost. I just know every time I step on the floor I feel like we can win games,” said Murray, who had 14 points, 10 assists and eight rebounds in his lone game with the Pelicans. "That’s just my mentality, and I feel like it can carry over to a lot of guys.” AP NBA: https://apnews.com/hub/NBA
Chargers focused on avoiding a letdown and not a potential playoff berth in matchup with Patriots
SF Dems pass new assault, harassment policies
Revealed: Killer guilty of beating two-year-old girl to death was also accused of controlling ex-girlfriend and got into prison fights while on remand By TOM RAWSTORNE Published: 15:24 GMT, 23 November 2024 | Updated: 15:26 GMT, 23 November 2024 e-mail 2 View comments Child murderer Scott Jeff, who has been found guilty of killing two-year-old Isabella Wheildon, had also been accused of controlling and coercive behaviour by a former girlfriend, the Daily Mail can reveal. The woman, who cannot be named for legal reasons, claimed that the 24-year-old had restricted her access to social media and kept her away from her family. The allegation emerged during legal argument in the absence of the jury so could not be reported until the end of the trial. On Friday, Jeff was found guilty of murder while Isabella's mother, Chelsea Gleason-Mitchell, 24, was cleared. Both had denied the charge, but Gleason-Mitchell had admitted causing or allowing the death of a child. Details also emerged about Jeff's time on remand in prison. It was claimed that he had got in to fights, with Gleason-Mitchell's barrister telling Ipswich Crown Court that he had resorted to violence 'in a frenzy of anger'. A recorded phone conversation in prison had shown him saying that he had 'lost it' with a cell-mate and 'just f***** snapped' when 'everything went to s***'. Gleason-Mitchell's defence team also wanted to bring up evidence of him seeking cocaine while in prison on remand. Scott Jeff, who has been found guilty of the murder of two-year-old Isabella Wheildon, had also been accused of controlling and coercive behaviour by a former girlfriend Details also emerged about Jeff's time on remand in prison. It was claimed that he had got in to fights and had resorted to violence 'in a frenzy of anger' Claims made in the absence of a jury also included that Jeff had exerted control against Chelsea Gleason-Mitchell, pictured with her daughter, Isabella They claimed the information about his temper and drug use was relevant to the case, and that Jeff had exerted a similar level of control against Gleason-Mitchell. But judge Mr Justice Garnham ruled that the information could not be put to the jury, partly due to inconsistencies in her evidence. He said, for instance, that she had continued to have access to the internet through an Amazon tablet while with Jeff, even when her phone was broken. The judge also ruled that evidence of Jeff losing his temper did not suggest who was responsible for Isabella's injuries. It can also today be revealed how Gleason-Mitchell had been suspended from her job as a nursery nurse for pushing a child. She had been working at Busy Bees nursery in Sandy, Bedfordshire for five months when the alleged incident took place in July 2022. She was immediately suspended and the incident referred to the local authority. It ordered an internal investigation which found no evidence to support the claim and Gleason-Mitchell was allowed to resume work. 'I was told that Chelsea was suspended because a child went home and told her mother that Chelsea had hit her,' a former colleague told this newspaper. 'I heard that Chelsea's reasoning for that was that she was not hitting her but that when they put them to bed they would tap their bottoms.' A jury convicted Scott Jeff, 24, of the murder of two-year-old Isabella Wheildon after deliberating for just over seven hours It can also be revealed that Gleason-Mitchell had been suspended from her job at Busy Bees nursery in Sandy, Bedfordshire for allegedly pushing a child in July 2022 Police mugshots of Gleason-Mitchell and Scott Jeff as both await sentence for their crimes A source from the nursery insisted that the allegation had not involved hitting or smacking a child – but pushing one. She added that the original investigation had been reviewed following Gleason-Mitchell's arrest and that no other complaints had been received and that there were no concerns about her work. Read More BREAKING NEWS Boyfriend, 24, is found guilty of murdering two-year-old girl as cruel mother watched on Gleason-Mitchell's two-year-old daughter Isabella attended the same nursery in Sandy along with her mother, under an arrangement whereby staff are offered reduced fees. She quit her job in April of last year, having split up with the father of her child, Thomas Wheildon. Within weeks she had begun a relationship with Scott Jeff and the couple left Bedfordshire for East Anglia, where Isabella was subjected to weeks of abuse that led to her death. Ipswich Crown Court heard Gleason-Mitchell described as a 'vulnerable' individual with 'intellectual struggles'. The colleague, who worked with her at a previous nursery, described Gleason-Mitchell as 'odd'. 'The DBS checks are run but they're crying out for people to work with children,' she said. Isabella, pictured here on a swing with her mother Chelsea Gleason-Mitchell, was found dead at a homeless unit in Ipswich, Suffolk Within weeks of beginning a relationship Jeff and Gleason-Mitchell left Bedfordshire for East Anglia, where Isabella was subjected to weeks of abuse that led to her death 'She was awkward and giggled over anything. She had a nervous disposition about her. I found her uncomfortable to be around so I made a point of not being friendly with her. 'She made my skin crawl and she made me feel on edge. I was annoyed by her. There was constant giggling.' And she added: 'Chelsea would not do much. She would just sit with a baby in her lap and have a cuddle all day. We would have to pull her up on that. 'The job is not just about cuddles. It's about safeguarding and cleaning and preparing meals. 'I never saw her being rough with any of the children. All I can remember is her sitting down with a baby in her lap.' Amazon Share or comment on this article: Revealed: Killer guilty of beating two-year-old girl to death was also accused of controlling ex-girlfriend and got into prison fights while on remand e-mail Add comment