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    FDA - Medical Device News

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    Yahoo! News - Biotechnolgy

    • Gene Cernan, last astronaut to walk on the moon, dies at 82
      HOUSTON (AP) — Astronaut Gene Cernan traced his only child's initials in the dust of the lunar surface. Then he climbed into the lunar module for the ride home, becoming the last person to walk on the moon.
      - 1 day ago, 17 Jan 17, 3:40pm -
    • Gene Cernan, last astronaut to walk on moon, dies at 82
      Cernan, who was also the second American to walk in space, died surrounded by his family, the National Aeronautics and Space Administration said in a statement without providing details. Cernan and fellow Apollo 17 astronaut Harrison Schmitt became m…
      - 1 day ago, 17 Jan 17, 3:02pm -
    • Gene Cernan, last astronaut to walk on the moon, dies at 82
      HOUSTON (AP) — Astronaut Gene Cernan traced his only child's initials in the dust of the lunar surface. Then he climbed into the lunar module for the ride home, becoming the last person to walk on the moon.
      - 2 days ago, 17 Jan 17, 3:19am -
    • Gene Cernan, last astronaut to walk on the moon, dies at 82
      Former astronaut Gene Cernan, who as the last person to walk on the moon returned to Earth with a message of "peace and hope for all mankind," died on Monday, his family said. He was 82. Cernan ...
      - 2 days ago, 17 Jan 17, 12:24am -
    • Gene Cernan, last astronaut to walk on moon, dies at 82
      Cernan, who was also the second man to walk in space, died surrounded by his family, the National Aeronautics and Space Administration said in a statement without providing details. Cernan and fellow Apollo 17 astronaut Harrison Schmitt became member…
      - 2 days ago, 16 Jan 17, 10:39pm -
    • Investors in big pharma, biotech look to ride out Trump storm
      Investors in large U.S. pharmaceutical and biotech companies are counting on strong dividends, reasonable stock valuations and new products to help ride out a storm of political uncertainty as the incoming Trump administration dives into healthcare p…
      - 6 days ago, 12 Jan 17, 8:27pm -
    • As Trump meets biotech CEOs, farm advisers fret over empty USDA spot
      U.S. President-elect Donald Trump has left the agriculture secretary as the last department head to be named to his Cabinet, while a meeting with the chief executives of two agribusiness giants gave a hint at a roster of farm issues the incoming pres…
      - 6 days ago, 12 Jan 17, 12:12pm -
    • New Illumina tech could usher in $100 gene-sequencing era
      (Reuters) - Shares of Illumina Inc rose 16 percent on Tuesday, after the company unveiled new technology, which is expected to eventually reduce the cost of sequencing to $100 per human genome, prompting a slew of price target increases. It took gove…
      - 8 days ago, 10 Jan 17, 5:42pm -
    • U.S. chief justice steps aside in patent case over stock conflict
      U.S. Chief Justice John Roberts will no longer participate in a patent dispute at the Supreme Court involving a unit of Thermo Fisher Scientific Inc after he realized he owns about $175,000 of stock in the company, the court said on Wednesday. The ei…
      - 14 days ago, 4 Jan 17, 10:53pm -
    • FDA OKs first treatment for rare genetic disorder
      WASHINGTON (AP) — The Food and Drug Administration on Friday approved the first treatment for children and adults with spinal muscular atrophy, a rare genetic disorder marked by progressive muscle weakness that's the most common genetic cause of de…
      - 26 days ago, 24 Dec 16, 12:29am -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • 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…
        - 20 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 →
        - 33 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…
        - 34 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 →
        - 35 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 →
        - 47 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 →
        - 50 days ago, 29 Nov 16, 11:16am -
      • Local Ballot Initiatives Impacting Health and Healthcare
        There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may influence how other … Continue reading →
        - 69 days ago, 10 Nov 16, 6:09pm -
      • FDA Seeking Even More Input on Character Space Limitation
        This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective…
        - 70 days ago, 9 Nov 16, 1:45pm -
      • Weekly Roundup 11.4.16
        We are almost through it!  Just a few more days. In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be … Continue reading →
        - 75 days ago, 4 Nov 16, 10:21am -
      • Weekly Roundup 10.28.16
        It has been way too long since a Weekly Roundup and way too long since a regular posting. The autumn has turned out to be an exceptionally busy time so apologies on both fronts. But today I’m carving out a … Continue reading →
        - 82 days ago, 28 Oct 16, 1:33pm -