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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 data firm that misused Facebook user data and had ties to President Donald Trump's 2016 election campaign is closing.The SCL Group, a British affiliate of Cambridge Analytica, will also shut down, the Wall Street Journal reports.WSJ says "a person familiar with the matter" said the company is losing clients and has mounting legal fees as a result of the Facebook issue.Cambridge Analytica issued a news release on Wednesday announcing it is ceasing operations in the U.K. and U.S."Parallel bankruptcy proceedings will soon be commenced on behalf of Cambridge Analytica LLC and the certain of the Company's U.S. affiliates in the United States Bankruptcy Court for the Southern District of New York," the release states.In his keynote address at the F8 summit on Tuesday, Facebook CEO Mark Zuckerberg addressed ongoing data privacy scandals, including election meddling issues and fake news problems. He said the company must keep a sense of optimism as it tackles the issues.Facebook announced it will soon launch a new privacy feature that will allow users to clear their browsing history of Facebook, including what websites they have visited and what they click on. 1212

The coronavirus pandemic has had a big impact on businesses of all kinds, restaurants and retailers alike are closing permanently and others are doing what they can to financially survive.That also means it could be a good time for consumers looking for specific items to save some money.The website rather-be-shopping.com compiled a list of 13 items that have become cheaper during the pandemic.Items like clothing for the whole family. Retailers like Macy’s, Stein Mart, Ann Taylor, and many more are closing anywhere from several stores to most of them. That could mean deep discounts during liquidation sales.Those looking for a home or want to refinance will find low mortgage rates right now. Mortgage rates have hit an all-time low.Gas is about 50 cents cheaper nationally than it was in the summer of 2019. Maybe it’s time for a road trip or long drive and save on fuel prices.That also contributes to low shipping costs. Many online sites are offering no or low shipping costs right now.In time for school to start, technology is cheaper and many places are offering discounts on laptops and electronic devices and headphones that can be used for at-home learning. There are also 16 states with "no sales tax" weekends to encourage shopping. 1259

The company that owns GEDmatch, the DNA analysis site that police in California used to catch the so-called Golden State Killer, said hackers attacked their database and exposed users' DNA profile data to law enforcement searches.In a statement posted on Facebook, Verogen said they took down their website after being hit by two security breaches on July 19 and July 20.The company stated that GEDmatch profiles were exposed to law enforcement agencies in an “orchestrated through a sophisticated attack on one of our servers via an existing user account.""As a result of this breach, all user permissions were reset, making all profiles visible to all users," the company said in the statement. "This was the case for approximately 3 hours. During this time, users who did not opt-in for law enforcement matching were available for law enforcement matching, and, conversely, all law enforcement profiles were made visible to GEDmatch users."GEDmatch rose to face in 2018 when their site was used by law enforcement to match the DNA to nab Joseph James DeAngelo, who's also known as the Golden State Killer.DeAngelo pled guilty to 13 murders back in June, CBS News reported.The company says the site should be back up and running by Saturday. 1251

The current spike in COVID-19 cases is stressing the testing system across the country.As the virus spreads at unprecedented rates, more Americans are seeking COVID-19 tests. But in recent days, companies that make the tests and the supplies needed for them are struggling to keep up with demand."Those companies were operating on an allocation basis, and that just means that basically everything they make is going out the door," said Kelly Wroblewski, the Director of Infectious Disease Programs at the Association of Public Health Laboratories. "There is no reserve, so there's an increased demand in a lab for testing. There's no more reagent to be had, so to meet that demand, that lab has to use a different manufacturer's test."Wroblewski adds that along with issues in getting supplies, officials are also short on human resources — there is only so much lab capacity and only so many trained people to conduct the tests.The American Clinical Laboratory Association says the surge in demand for testing means some labs could reach or exceed their current testing capacities soon — meaning it could take longer for patients to get PCR test results back.Wroblewski says that it can take currently take anywhere from 24 hours to a week to get PCR test results back.With antigen tests, patients can get results back in less than 30 minutes. There is currently enough of a supply for antigen tests, but not all facilities offer them.Both lab groups stress that COVID-19 testing is important, but patients should be strategic."There's been a lot of emphasis put on testing, but testing is only one piece of the puzzle," Wroblewski said. "It gives you some information, and if you're not going to do anything with that information — whether it be targeted closures. whether it be staying home and isolating — we're not going to stop the spread of disease."As far as getting more tests, it's going to take a while. Wroblewski says it could take up to six months or more to increase production capacity significantly. Labs don't expect to see a ramp-up in supplies until early 2021. 2090

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