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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 flower fields have been around for 50 years. The Flower Fields are owned and operated by the Ecke Family, the onsite grower and floral sales is handled by Mellano and Company. They share their passion for beauty and expertise inthe flower business, with a combined experience of 100 years.The Flowers Fields are known all over the world. There is no other place like it with over 50 acres of ranunculus flowers in 13 different colors. The flowers are delicate, its seed is tiny, paper thin, and smaller than an oat flake. The seed has to be mixed with water and sand, then it is placed in a cooler for two weeks to trick the seed into thinking it had a winter. Ranunculus do best in temperate climate. Morning fog, cool mornings, and temperatures in the 50s and 60s help the flower production. The flower fields are ecofriendly, they use a drip irrigation system. It places water exactly where the seed is, using the water needed and not more than that.Extreme temperatures can be costly and one of the biggest threats to the crop. Winter warm ups are less than ideal but too much rain is also bad. The team at the Flower Fields has learned to tackle the weather, but every year presents new challenges. This year they are expecting the best season yet, you can visit the Flower Fields through Mother’s Day weekend. Next year expect a new color to be added to the already beautiful fields. 1402

The four former police officers who were involved in an arrest that led to the death of George Floyd will asked a judge Friday that their cases be tried separately.In a hearing scheduled on Friday local time in Minneapolis, attorneys for Derek Chauvin, J. Alexander Kueng, Thomas Lane and Tou Thao asked Judge Peter Cahill that it will be "impossible" to evaluate each individuals' actions "in a vacuum," according to the Associated Press.According to the Minneapolis Star-Tribune, prosecutors opposed the requests, noting that witnesses and Floyd's family members are likely to be "traumatized" by multiple trials. They also argued that the "interests of justice" necessitate a single trial."Here, all four Defendants worked together to murder Floyd: Chauvin, Kueng, and Lane pinned Floyd face-down, while Thao stopped the crowd from intervening, enabling the other Defendants to maintain their positions. Defendants also discussed and coordinated their actions throughout the incident," prosecutors wrote in a court filing, according to The Associated Press.The Associated Press also reports that the request by the defendants indicates that the officers will seek to blame each other for Floyd's death. Attorneys for Lane and Kueng have already claimed that because their clients were rookies at the time, they were following the lead of Chauvin.The Star-Tribune also reports that the officers' attorneys sought a change of venue for the trial. Among their concerns about holding the trial in Minneapolis is a "tainted" jury pool.Judge Cahill took all of the defense's requests under advisement, according to ABC News. He did grant their request that four attorneys for the prosecution be dismissed from the case.Cahill said Hennepin County Attorney Mike Freeman and the three other attorneys should be dismissed from the case because they discussed autopsy results with the medical examiner, according to ABC.Defense attorneys have also filed a motion to dismiss the case, but the Star-Tribune reports that the judge is unlikely to discuss that motion Friday.Chauvin has been charged with second-degree unintentional murder, third-degree murder and second-degree manslaughter. The other three officers are charged with aiding and abetting murder and manslaughter.A trial date has been set for March 2021.Floyd died as officers attempted to arrest him for allegedly using counterfeit bills to buy tobacco on Memorial Day weekend. Bystander video showed Chavin kneeling on Floyd's neck for more than eight minutes as Floyd cried for help. All four officers were fired in the days following Floyd's death.Floyd's death sparked a massive wave of protests against police brutality and systemic racism across the country. 2727

The former head of USA Gymnastics has been accused of removing documents linked to the Larry Nassar sexual abuse case from the famed Karolyi Ranch gymnastics training facility in Texas, authorities said.Steve Penny was arrested Wednesday nearly three weeks after he was indicted by a grand jury for tampering with evidence, the Walker County District Attorney's office said.He was detained after US Marshals tracked him to a cabin in Gatlinburg, Tennessee. He is being held at the Sevier County Jail while awaiting extradition to Walker County, Texas.If convicted of the third-degree felony charge, Penny could face up to 10 years in prison and up to a ,000 fine.The indictment claims Penny ordered the removal of documents from the Karolyi Ranch in Walker County, Texas with "the purpose of impairing the ongoing investigation by destroying or hiding the documents," after he learned the investigation was underway, the Walker County District Attorney's office said.Authorities claim the documents were later delivered to Penny at the USAG headquarters in Indianapolis, Indiana. The records are currently missing.The documents would have helped law enforcement investigate Nassar and would have "assisted with the investigation of other offenses that may have occurred at the Karolyi Ranch," the district attorney's office said in a statement. 1370

The Dalai Lama has a new fan. And so does Aaron Rodgers. Each other.The Green Bay Packers' all-world quarterback is on a world trip taking him to India, where he met the Tibetan buddhist leader and gave him an NFL football and a Green Bay Packers hat.Rodgers and his beloved, Danica Patrick, are traveling to India to help with the Starkey Hearing Foundation, according to the Green Bay Press-Gazette. They will be giving hearing aids to some people who may be hearing for the first time.Rodgers has undergone a long spiritual journey beyond his time as a quarterback with the Packers. He often expressed his Christian faith during his rookie year in 2005, won the Bart Starr award which reflects on that belief. Yet he talked in 2016 about his spirituality, not necessarily believing God has one team he roots for over another, and the specifics of his purpose on earth. 879