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The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.___AP Medical Writer Lauran Neergaard contributed to this report.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5644

The coronavirus pandemic put the country on pause, but now that some cities and states are opening back up, what will that mean for the future of events?Kamron Khan has a lot of thoughts about that question. The professional photographer owns Kamron Khan Photography based in Cleveland and usually photographs large events, with hundreds of people that are booked a year or more in advance.That was until the novel coronavirus pandemic hit, and suddenly she found that one event after the next was rescheduled indefinitely or canceled all together.“It’s been really tough from thinking I was going to have one of my best years ever to no income,” said Khan.Everything from the 2020 Olympics to the remainder of the NBA season, the lights of Broadway to the lights of Hollywood – big events, and events that are only big to those involved have been postponed or canceled around the world.Khan, despite the drop in income, said she understands the caution.“I'm very concerned because I get a lot of these events that people are having, are big life moments - weddings to baby showers - you have all of these different types of things and you want to celebrate and I get that, but sometimes people just need to take a step back and realize ‘Hey you know what, why don't we celebrate next year? Why don’t we just keep it small, wait for things to die down?’ And I in no way think anyone's overreacting, but I would rather overreact and cancel things now than to have things go downhill and then it be much worse,” said Khan.She said right now she has a hard time imagining when events with hundreds of people will be commonplace again.“Right now, I can't until [infections] really change and really start going down in a downward trend. I can't even think about having these large gatherings and I think a lot of people don't want to anyway. Even if we were allowed to,” said Khan.The Centers for Disease Control and Prevention issued guidance about big gatherings now and in the future. The CDC suggests that event organizers do things like provide supplies to prevent the spread of COVID-19, including hand sanitizer and disposable facemasks. The CDC also urged event organizers to discourage people who are vulnerable to the disease -- like older adults – from coming to events at all.The guidance also states that, “Organizers should continually assess, based on current conditions, whether to postpone, cancel, or significantly reduce the number of attendees (if possible) for mass gatherings.”Nick Borelli, a marketing and live event expert, said that at least in the next year or so, people should expect to see smaller, more local events. He said those first events will also likely have cultural significance – like a city’s celebration or a big concert – rather than a conference or trade show.Borelli also said that in order for people to gain confidence going to events again, any initial events would need to be successful - with no new infection clusters.“If [cultural events] happen, it will just happen with an increased amount of trust, knowing that people want things to be the way that they were. So there is the push for what the bias is a confirmation bias. They want things to be that way, they're just looking for it,” said Borelli.He also said that as far as virtual events go, it’s easy to see which events will likely stay virtual in the future by looking at how different industries are planning right now.“Weddings are being postponed with the hopes to come back as they were,” said Borelli. “Corporate is making a move to adjust things to the cliché of new normal, which at the very least, be a world of hybrid [partially online and partially in person] for quite some time and probably sticking to a percentage of that.”Those virtual events offer their own unique challenges and triumphs. There isn’t that real, in-person interaction, but there is the potential to reach more people who may not have been able to take time off or afford to go to a conference.Borelli also said right now offers a great opportunity to gather data about the events that are happening online right now – to better see what things work better virtually.“I think that depending on the data that we collect in this time, and then also in the time that comes next, we can potentially prove our value in a black and white way that we never able to before,” said Borelli.For those in the event industry right now Borelli acknowledged that there is pain and not everyone will survive. And for those who do survive, it will look and be different for a long time.Khan said her new normal will – among other things – mean wearing a mask for the foreseeable future.“For myself, I'll definitely be wearing a mask whether I'm photographing people inside or outside, I just want to,” said Khan. “Not just protect myself, but I want to show others how people look at me and realize I'm doing everything that I need to be doing.” 4928

The former Dean of the Michigan State University College of Osteopathic Medicine and boss of Dr. Larry Nassar is facing four different charges, including criminal sexual conduct, after his arrest on Monday night.According to a court record, William Strampel is charged with fourth degree criminal sexual conduct, two counts of willful neglect of duty and common law offenses.Fourth degree CSC includes force or coercion. It's expected Strampel will be arraigned on these charges in Ingham County on Tuesday afternoon. 530

The FDA is offering formal guidance on the amount of inorganic arsenic allowed in infant rice cereal.Exposure to inorganic arsenic has been associated with neurodevelopmental effects, according to the Food and Drug Administration, including lung and bladder cancer risk. Arsenic occurs naturally in the soil, and rice has been shown to absorb a small amount during the growing process.The new guidance identifies a level of at or below 100 micrograms per kilogram and is based on draft guidance from 2016. The guidance is recommended, but not legally enforceable.“It is important to note that the agency’s data show that most products on the market are already below this level and that parents and caregivers should know that a well-balanced diet also includes a variety of grains like oats and barley,” said a statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.According to the FDA, results from testing in 2018 showed 76 percent of samples were at or below the 100 ppb level, compared to 47 percent of samples tested in 2014 and 36 percent of samples tested between 2011-2013.The FDA attributes the drop in inorganic arsenic presence to changes manufacturers are making in sourcing rice and testing their ingredients. 1279

The COVID-19 pandemic has been forcing millions of Americans to work and learn from home for several months at this point.But while working and learning from home may be routine, that hasn't made it any easier — meetings are still being sabotaged with rambunctious pets, unreliable WiFi signals and barely-clothed family members.Then, there's the dreaded mute button. Failing to click it (or mistakenly turning it off) has sunk many a meeting in the last five months.And apparently, U.S. senators aren't immune to mute-button woes.During the Senate Committee on Homeland Security and Governmental Affairs' questioning of Postmaster General Louis DeJoy on Friday, Chairman Ron Johnson (R-Wisconsin) recognized Sen. Tom Carper (D-Delware) for questioning. After a few moments, Carper didn't respond, and Johnson moved on to Sen. James Lankford (D-Michigan).Apparently, Carper was at his computer but muted. And when audio was restored to his microphone, it caught the senator frustratingly releasing a series of expletives.Johnson asked if Carper was able to unmute his laptop, adding "we don't want to be on TV again," with a laugh.Following the snafu, Carper was able to conduct his questioning.Later, Carper joked about the incident on Twitter."Those who know me know that there are few things that get me more fired up than protecting the Postal Service! #DontMessWithUSPS," he tweeted. 1396