Tag: rejected
US Regulators Rejected Neuralink’s Bid To Test Brain Chips In Humans, Citing Safety Risks
Neuralink has not disclosed details of its trial application, the FDA’s rejection or the extent of the agency’s concerns. As a private company, it is not required to disclose such regulatory interactions to investors. During the hours-long November presentation, Musk said the company had submitted “most of our paperwork” to the agency, without specifying any formal application, and Neuralink officials acknowledged the FDA had asked safety questions in what they characterized as an ongoing conversation. Such FDA rejections do not mean a company will ultimately fail to gain the agency’s human-testing approval. But the agency’s pushback signals substantial concerns, according to more than a dozen experts in FDA device-approval processes.
The rejection also raises the stakes and the difficulty of the company’s subsequent requests for trial approval, the experts said. The FDA says it has approved about two-thirds of all human-trial applications for devices on the first attempt over the past three years. That total rose to 85% of all requests after a second review. But firms often give up after three attempts to resolve FDA concerns rather than invest more time and money in expensive research, several of the experts said. Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device.
Read more of this story at Slashdot.
Matt Hancock ‘rejected Chris Whitty’s advice on care home testing’ as Covid ravaged Britain
MATT Hancock rejected Chris Whitty’s advice to test “all people going into care homes” as Britain was hit by the Covid pandemic.
Leaked WhatsApp messages reveal the ex-Health Secretary at first welcomed the chief medical officer’s suggestion as a “good positive step”.
Mr Whitty gave his advice early in April 2020 — about a month into the pandemic[/caption]
But he then changed his mind.
He told officials he only wanted to test people entering care homes from hospital — not those from the wider community.
In messages leaked to the Daily Telegraph, Mr Hancock said doing both would “muddy the waters” — asking officials to “tell me if I’m wrong”.
Mr Whitty gave his advice early in April 2020 — about a month into the pandemic.
Mr Hancock introduced guidance that made testing mandatory for those entering from hospital.
But guidance calling for those coming in from the community to be tested too was not introudced until August 14.
A total of 17,678 people died of Covid in care homes in England between April 17 and August 13.
Last night a spokesperson for Mr Hancock said: “The story spun on care homes is completely wrong. What the messages show is that Mr Hancock pushed for testing of those going into care homes when that testing was available.”
The WhatsApp messages also revealed he and his team set up a group chat called “crisis management” to deal with the comms fallout after
The Sun revealed he had broken lockdown rules and was having an affair with his aide, Gina Coladangelo.
A spokesperson for Matt Hancock said: “It is outrageous that this distorted account of the pandemic is being pushed with partial leaks, spun to fit an anti-lockdown agenda, which would have cost hundreds of thousands of lives if followed.
“What the messages do show is a lot of people working hard to save lives.
“The full documents have already all been made available to the inquiry, which is the proper place for an objective assessment, so true lessons can be learned.
“Those who argue there shouldn’t have been a lockdown ignore the fact that half-a-million people would have died had we not locked down.
“And for those saying we should never lock down again, imagine if a disease killed half those infected, and half the population were going to get infected – as is happening right now with avian flu in birds. If that disease were in humans, of course we’d want to lockdown.
“The story spun on care homes is completely wrong. What the messages show is that Mr Hancock pushed for testing of those going into care homes when that testing was available.
“Instead of spinning and leaks we need the full, comprehensive inquiry, to ensure we are as well prepared as we can be for the next pandemic, whenever it comes.”
Matt Hancock rejected Sir Chris Whitty’s call to test all residents going into care homes for Covid
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‘Menopause leave’ trial rejected by ministers
Activision Blizzard appeal against Blizzard Albany QA union vote rejected
An appeal made by Activision Blizzard that blocked Blizzard Albany’s QA staff from unionising has been rejected by the US National Labor Relations Board (NLRB). GIbiz report the publisher tried to argue that the entire staff of Blizzard Albany should vote on the unionisation effort rather than just the development studio’s QA team, but the NLRB disagree.
Erik ten Hag suffers blow in Man Utd revamp as third Ajax reunion rejected
Apple Rejected Spotify’s App Update Adding Audiobook Support
Over the years, Apple and Spotify have had a long running dispute over Apple’s App Store policies, with multiple public conflicts over app and subscription fees and app rejections due to Spotify’s attempts to skirt the up to 30 percent cut that Apple takes from purchases.
Apple says that Spotify is again trying to get around its App Store rules, and the Cupertino company claims that Spotify’s audiobooks update is not in line with guidelines that cover how apps can communicate with users about purchasing options outside of the App Store.
Apple last year agreed to an App Store rule change that allows developers to use communications like email to share information methods about payment options that are available outside of an iOS app, but Spotify is running into issues attempting to implement this feature. With the rule change, Spotify wanted to direct customers to buy books online to listen to in the app, rather than giving Apple a cut of its audiobook sales.
Apple apparently told Spotify that it can send customers emails about online purchases, but Spotify is not able to offer a button inside of the app to request emails. The feature was designed with Spotify’s legal team involved, and Apple initially approved the update in September, but later reversed course, rejecting subsequent updates.
Spotify designed a nine-step process for purchasing an audiobook, which involved a customer tapping on an audiobook and seeing a screen with a lock over the play button. Pressing on the play button provided customers with a page where they could request information on how to buy a book through an email, and the email offered up a link to purchase the book.
An Apple spokesperson told MacRumors that Apple “has no issues” with reader apps like Spotify adding audiobook content, but Spotify did not follow Apple’s guidelines around in-app communications directing users outside the app.
The App Store was designed to be a great business opportunity for developers, and we fully support initiatives to introduce new features in apps that provide lasting value for users. We have no issue with reader apps adding audiobook content to their apps, linking users out to websites to sign up for services, or communicating with customers externally about alternative purchase options. The Spotify app was rejected for not following the guidelines regarding including explicit in-app communications to direct users outside the app to make digital purchases. We provided them with clear guidance on how to resolve the issue, and approved their app after they made changes that brought it into compliance.
After the multiple rejections from Apple, Spotify released a version of the app that removes information about how to purchase an audiobook from the Spotify website, which Apple did approve. Spotify now informs users that there is no option to buy an audiobook in the app. “We know it’s not ideal,” says Spotify in the app text.
Spotify in 2019 filed a regulatory complaint with the European Union over Apple’s App Store practices, and it maintains an anti-Apple “Time to Play Fair” website. Spotify has continued to meet with European regulators, but the case has not concluded as of yet. Spotify has also sided with Epic Games in the Epic Games v. Apple legal battle, and it participates in the “Coalition for App Fairness” alongside Epic Games, Tile, and others who are unhappy with Apple’s “anti-competitive” policies.
This article, “Apple Rejected Spotify’s App Update Adding Audiobook Support” first appeared on MacRumors.com
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