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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 company that makes Cream of Wheat says it is initiating an immediate review of its brand and packaging as the nation's institutions hold ongoing conversations about race amid weekslong protests."B&G Foods, Inc. today announced that we are initiating an immediate review of the Cream of Wheat brand packaging," the company said in a statement Wednesday. "We understand there are concerns regarding the Chef image, and we are committed to evaluating our packaging and will proactively take steps to ensure that we and our brands do not inadvertently contribute to systemic racism."Cream of Wheat's packaging includes an image of a black chef. In early advertisements, copy refers to the chef as "Rastus" — a term now considered a slur. The name refers to a minstrel show caricature of a stereotypically happy black man.Cream of Wheat follows in the footsteps of Aunt Jemima pancake mix, which announced Wednesday that it would drop its mascot (also rooted in minstrel show tropes) and change its name. Uncle Ben's rice, which also uses a black man's portrait on its packaging, said it planned to "evolve" the brand, but did not offer specifics.Protests against systemic racism and police brutality across the country were sparked by the death of George Floyd, a black man who died in police custody in Minneapolis. Bystander video from Floyd's arrest showed a police officer, later identified as Derek Chauvin, kneeling on Floyd's neck for more than eight minutes. 1478

The Centers for Disease Control and Prevention say four people have died and 11 others have been hospitalized after they ingested hand sanitizer.In the report, the CDC said the 15 adults, 13 of which were men, were being treated for methanol poisoning, which occurred in New Mexico and Arizona between May and June.The CDC said three people suffered vision problems."Alcohol-based hand sanitizer products should never be ingested," CDC officials said in the report. "In patients with compatible signs and symptoms or after having swallowed hand sanitizer, prompt evaluation for methanol poisoning is required. Health departments in all states should coordinate with poison centers to identify cases of methanol poisoning."As of July 8, four people were still hospitalized, the report stated."Among the four patients who died, three had seizures at the time of admission; initial signs and symptoms were not reported for the fourth patient," the report said.According to the report, the average age was 43, with some of the incidents happening amongst Native Americans. 1076

The death toll in the deadliest wildfire in California history continues to increase as Cal Fire officials said on Tuesday that six more bodies were found, marking the Camp Fire's death toll at 48. The six bodies were found in Paradise, California, a town that authorities said was destroyed by the Camp Fire, which is only 30 percent contained as of Tuesday. The Camp Fire alone has destroyed 8,817 structures and continues to spread. The fire is spreading despite nearly 5,000 fire personnel responding to the fire, Cal Fire said. Unfortunately, the Camp Fire is just one of several wildfires raging currently. The Woolsey Fire, which has claimed two lives of its own, continues to spread throughout Ventura County, California. That fire has spread across nearly 100,000 acres since being spotted on Nov. 7.  858

The economy is humming. Americans are eager to spend on clothes, toys and home decor.Just not at JCPenney.Leaderless, billion in debt and with a stock price below , the besieged retailer faces an uncertain fate after posting its latest round of dismal earnings."They're in a leaky boat that eventually will sink," said Mark Cohen, the director of retail studies at the Columbia Business School and a former CEO of Sears Canada and other department stores. "The prognosis for the future is not happiness."Penney finds itself weighed down by years of errors, failed CEOs and muddled attempts to establish a clear identity with shoppers. 652