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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 Department of Justice said Monday that an NYPD officer had been arrested and charged with allegedly acting as an "illegal agent" for the Chinese government.In a statement released Monday, the DOJ said that in addition to illegal agent charges, 33-year-old Baimadajie Angwang has also been charged with committing wire fraud, making false statements and obstructing an official proceeding.The DOJ alleges that Angwang was providing information about Chinese citizens in the New York area to the government of the People's Republic of China. He was also allegedly "developing intelligence sources within the Tibetan community."According to Scripps station WPIX in New York, Angwang is a Tibetan native and resident of Long Island. He worked in the NYPD's 111th precinct in Queens and was also employed by the U.S. Army Reserve as a staff sergeant.Angwang initially arrived in the U.S. on a cultural exchange visa. Once that visa was renewed, he overstayed the length and later claimed asylum "on the basis that he had allegedly been arrested and tortured" in China due to his Tibetan heritage.A complaint alleges that Angwang has worked under the control of the Chinese government since 2014. He allegedly told his Chinese government handler that he wanted to be promoted within the NYPD "so that he could assist the PRC and bring 'glory to China.'""As alleged in this federal complaint, Baimadajie Angwang violated every oath he took in this country. One to the United States, another to the U.S. Army, and a third to this Police Department," NYPD Commissioner Dermot Shea said. "From the earliest stages of this investigation, the NYPD's Intelligence and Internal Affairs bureaus worked closely with the FBI's Counterintelligence Division to make sure this individual would be brought to justice.""The defendant allegedly violated the trust of his community and the New York City Police Department on behalf of a foreign power, the People's Republic of China. This type of conduct simply cannot be tolerated," said Alan E. Kohler, Jr., Assistant Director of the FBI's Counterintelligence Division. "This case serves as yet another reminder that China represents the biggest counterintelligence threat to the United States and that the FBI and our partners will be aggressive in investigating and stopping such activities within our nation."If convicted, Angwang faces a maximum of 55 years in prison. 2412

The E. coli outbreak linked to romaine lettuce has sickened 43 people in 12 states, the US Food and Drug Administration said Monday.The FDA said that the ongoing outbreak is linked to the "end of season" harvest in some parts of California -- but the agency still says people should not eat any romaine lettuce.People have become sick in California, Connecticut, Illinois, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New York, Ohio and Wisconsin.An additional 22 people in Canada are also ill, so the FDA is coordinating its investigation with the Canadian health and food safety authorities, the agency said.When the outbreak was announced last week, the FDA and the Centers for Disease Control and Prevention warned consumers to stay away from all romaine lettuce, but the FDA said the investigation was focused on California and Mexico."Over the Thanksgiving holiday, the FDA continued to investigate the outbreak," according to a statement from FDA Commissioner Dr. Scott Gottlieb. "Our investigation at this point suggests that romaine lettuce associated with the outbreak comes from areas of California that grow romaine lettuce over the summer months, and that the outbreak appears to be related to 'end of season' romaine lettuce harvested from these areas. The involved areas include the Central Coast growing regions of central and northern California."Lettuce growing and harvesting in the winter months is taking place in California and Arizona's desert regions and Florida, as well as Mexico. Currently, the FDA investigation does not implicate lettuce from any of these areas.While the romaine supply undergoes a "clean break" to ensure all the contaminated lettuce is effectively gone from the market, the FDA has asked producers and distributors to provide clear labeling with the lettuce's date and origin in the future.A task force within the lettuce industry has also been established to determine better solutions for labeling long-term in order to help with tracing."Based on discussions with major producers and distributors, romaine lettuce entering the market will now be labeled with a harvest location and a harvest date," Gottlieb said. "Romaine lettuce entering the market can also be labeled as being hydroponically or greenhouse grown. If it does not have this information, you should not eat or use it."If consumers, retailers and food service facilities are unable to identify that romaine lettuce products are not affected -- which means determining that the products were grown outside the California regions that appear to be implicated in the current outbreak investigation -- we urge that these products not be purchased, or if purchased, be discarded or returned to the place of purchase."Symptoms of E. coli infection, which usually begin about three or four days after consuming the bacteria, can include watery or bloody diarrhea, fever, abdominal cramps, nausea and vomiting, according to the CDC. Most people infected by the bacteria get better within five to seven days, though this particular strain of E. coli tends to cause more severe illness.People of all ages are at risk of becoming infected with Shiga toxin-producing E. coli, according to the FDA. Children under 5, adults older than 65 and people with weakened immune systems, such as people with chronic diseases, are more likely to develop severe illness, but even healthy children and adults can become seriously ill. 3450

The first large head-to-head comparison of two opioid addiction medications found that, although they were equally effective in getting people off of high levels of opioids, users had a significantly more difficult time starting a regimen of naltrexone, compared with buprenorphine.Buprenorphine is commonly known by the the brand name Suboxone, and naltrexone is sold under the brand name Vivitrol.The study, published Tuesday in the Lancet, looked at 570 patients with opioid addiction at eight inpatient treatment centers across the country for 24 weeks. Half of the group was assigned to naltrexone and the other half to bupenorphine.Six percent of those enlisted to use buprenorphine were unable to start their treatment, whereas 28% of those assigned to naltrexone dropped out before starting the therapy. 824

The FBI raid on President Donald Trump's personal attorney Michael Cohen sought information that included payments allegedly made to keep women silent about affairs with Trump more than a decade ago.A source familiar with the matter told CNN Tuesday that a focus of the raid was to seek records on the deal set up between ex-Playboy Playmate Karen McDougal and a company that reportedly paid her amid the 2016 presidential campaign cycle to keep her account from publication. 483