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    FDA - Medical Device News - News

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    • newUK court: Income rule to bring in foreign spouses is lawful
      LONDON (AP) — Britain's Supreme Court ruled Wednesday that the government is entitled to set a minimum-income threshold for people wanting to bring foreign spouses to the country, a measure introduced to ensure that immigrants won't draw on public…
      - 3 hours ago, 22 Feb 17, 12:31pm -
    • newRussian defense minister happy with results of Syria mission
      MOSCOW (AP) — Russia's defense minister on Wednesday hailed the military's performance in Syria, saying new Russian weapons have proven their worth in the conflict.
      - 3 hours ago, 22 Feb 17, 11:41am -
    • newNew immigration ban order will still face legal challenges
      With a revised immigration ban executive order to be announced this week, the Trump administration hopes to avoid another legal entanglement. But based on the words of the judges and parties involved in the dispute, more controversy is likely to foll…
      - 4 hours ago, 22 Feb 17, 11:32am -
    • newBritain's top court backs government on immigration income test
      By Alistair Smout LONDON (Reuters) - Britain's top court backed a government attempt to limit immigration by ruling on Wednesday that an income test for those who want to bring their non-European spouses to the UK is acceptable and does not infringe…
      - 4 hours ago, 22 Feb 17, 11:29am -
    • newLloyds Banking Group posts surging profits
      Lloyds Banking Group announced soaring annual profits Wednesday on lower charges linked to an insurance scandal, as it awaits a full return to the private sector following a state bailout. LBG pointed to an "uncertain" economic outlook as Britain pr…
      - 5 hours ago, 22 Feb 17, 10:05am -
    • newEx-Hong Kong leader gets 20 months in jail for misconduct
      HONG KONG (AP) — A former leader of Hong Kong was sentenced Wednesday to 20 months in prison for misconduct after failing to disclose plans to rent a luxury apartment for his retirement from a businessman applying for a broadcasting license.
      - 10 hours ago, 22 Feb 17, 5:06am -
    • newPilot radioed in 'Mayday' call before Australian plane crash
      DALLAS (AP) — A pilot repeatedly yelled out "Mayday" but did not say what the emergency was before his light plane crashed into the roof of an Australian shopping mall, killing himself and four American tourists, an accident investigator said Wedne…
      - 10 hours ago, 22 Feb 17, 4:52am -
    • newHillary Clinton Finally Stepped in to Advise President Trump
      After months of passive tweets, Hillary Clinton finally called on POTUS speak out against anti-Semitic attacks. President Trump employed Breitbart News chairman, Steven Bannon, as chief Whitehouse strategist, leading some to believe he's encouraging…
      - 13 hours ago, 22 Feb 17, 2:06am -
    • newTeens accused of plot to rob, kill girl found shot in ditch
      LOGAN, Utah (AP) — Two teenage boys charged with shooting a 14-year-old girl in the back of the head and leaving her wounded in a ditch lured her to the spot in a small Utah town with a plan to rob and kill her, prosecutors said Tuesday.
      - 14 hours ago, 22 Feb 17, 12:57am -
    • newWomen's life expectancy on track to hit 90 in some nations
      By 2030 life expectancy for South Korean women could top nine decades, an average lifespan long thought to be out of reach, researchers said Wednesday. South Korea is not only the first country in the world where women may live past 90 on average, i…
      - 15 hours ago, 21 Feb 17, 11:47pm -

    Regulatory Affairs Pharma

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      Eye On FDA

      • AdComm Activity for 2016 – How Did They Vote?
        The number of new drugs approved by FDA last year fell – by many indicators. There were fewer new molecular entities approved and there were fewer press releases about approvals during the year compared to 2015. And consequently, there were … Con…
        - 8 days ago, 14 Feb 17, 11:36am -
      • Look Back at OPDP Enforcement in 2016 – Focus on Pre Approval Communications
        It was another year of low-level enforcement by the FDA Office of Prescription Drug Promotion (OPDP). In fact, if you added the number of letters issued over the past three years it would be one less than the number of … Continue reading →
        - 20 days ago, 2 Feb 17, 10:57am -
      • Regulation Cutting Impact on FDA and AdComms
        During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed. Now in office, this week…
        - 21 days ago, 1 Feb 17, 11:25am -
      • What They Said in 2016 – FDA Releases
        FDA ended the year quietly and began the new year in similar fashion. The holidays are of course a factor, but in all of October and November of 2016, there were only 3 releases issued for each month. Even in … Continue reading →
        - 27 days ago, 26 Jan 17, 6:29pm -
      • Additional Untitled Letters Issued by OPDP
        It has been a rather extraordinary month for watchers of the Office of Prescription Drug Promotion (OPDP) in that while the office has issued very little enforcement during the bulk of the year, December has been making up for it. … Continue readin…
        - 55 days ago, 29 Dec 16, 4:28pm -
      • Weekly Roundup 12.16.16
        It has been a while since there has been a Weekly Roundup posting, primarily because FDA has been fairly quiet of late. In fact, during October the agency issued only 3 press releases and the same for November. Certainly lots … Continue reading →
        - 68 days ago, 16 Dec 16, 1:40pm -
      • OPDP Makes a Point on Risk Info and DTC (Updated)
        The Office of Prescription Drug Promotion (OPDP) has been particularly low-key this year when it comes to visible enforcement actions expressed through the issuance of Warning or Untitled letters. Up until this week, the office had issued only 5 lett…
        - 69 days ago, 15 Dec 16, 3:45pm -
      • FDA – Fewer Approvals, Less to Talk About in 2016
        As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had … Continue reading →
        - 70 days ago, 14 Dec 16, 4:52pm -
      • New Directions for FDA, Part 2 – Regulatory Matters
        In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could … Continue reading →
        - 82 days ago, 2 Dec 16, 1:06pm -
      • New Directions for FDA, Part 1 – 21st Century Cures
        One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading →
        - 85 days ago, 29 Nov 16, 11:16am -