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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newPlan to dig up President Polk's body _ again _ stirs trouble
      NASHVILLE, Tenn. (AP) — President James K. Polk did big things for America, dramatically expanding its borders by annexing Texas and seizing California and the Southwest in a war with Mexico. Achieving undisturbed eternal rest has proved more diffi…
      - 5 hours ago, 24 Mar 17, 9:23pm -
    • newAt least 50 killed by armed men in CAfrica: locals
      At least 50 people have been killed and dozens more injured since Tuesday after armed men attacked three villages in the central Bambari region of the Central African Republic, local residents who fled their homes told AFP. "The provisional toll of…
      - 5 hours ago, 24 Mar 17, 9:20pm -
    • newPete Souza joins chorus gloating over Trumpcare failure with epic Instagram
      The schadenfreude online when Trumpcare collapsed for a second time was deafening. However, amid all the resurfaced Trump tweets and Art of the Deal jokes one troll stood out once again. Pete Souza, Obama's official White House photographer, added a…
      - 5 hours ago, 24 Mar 17, 9:15pm -
    • newPelosi Proclaims 'Victory' After GOP Yanks Health Bill
      House Minority Leader Nancy Pelosi calls Republicans decision to pull their bill to repeal Obamacare a "victory for the American people."
      - 5 hours ago, 24 Mar 17, 8:29pm -
    • newNorth Dakota governor approves concealed guns without a permit
      The law, which takes effect on Aug. 1, mandates that gun owners only need a North Dakota driver's license or state identification card for at least a year before they can carry a concealed firearm in public. Under current regulations, applicants mus…
      - 6 hours ago, 24 Mar 17, 8:08pm -
    • newWhite House Press Secretary Sean Spicer's daily briefing on March 24,2017
      On Friday, March 24, 2017, White House Press Secretary Sean Spicer hosts the daily press briefing with the White House press corp.
      - 7 hours ago, 24 Mar 17, 6:35pm -
    • newNorth Dakota oil spill 3 times larger than first estimated
      BISMARCK, N.D. (AP) — A December oil pipeline spill in western North Dakota might have been three times larger than first estimated and among the biggest in state history, a state environmental expert said Friday.
      - 11 hours ago, 24 Mar 17, 3:05pm -
    • newMissing D.C. Girls Could Be Human Trafficking Victims
      Some officials are calling for an investigation into the disappearances, while police maintain there is nothing unusual about them.
      - 12 hours ago, 24 Mar 17, 2:22pm -
    • newThe Mud Day in Israel
      The Mud Day, an international sports event is produced by a leading French sports organization, A.S.O., that is well known for its top productions: Le Tour de France and the Dakar Rally. More than 150,000 people have participated in Mud Days in Fra…
      - 12 hours ago, 24 Mar 17, 2:16pm -
    • newTrump turns up heat on House GOP before health care vote
      President Trump put pressure on the House of Representatives to pass the American Health Care Act (AHCA) Friday morning as its prospects looked bleaker. As expected, Trump bemoaned the Affordable Care Act (ACA), also known as Obamacare, claiming it…
      - 12 hours ago, 24 Mar 17, 1:43pm -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • The White House on FDA Approval Burden – Is There a There There?
        In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in ……
        - 22 days ago, 3 Mar 17, 12:42pm -
      • 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…
        - 39 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 →
        - 51 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…
        - 52 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 →
        - 57 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…
        - 85 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 →
        - 99 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…
        - 99 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 →
        - 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 →
        - 2 Dec 16, 1:06pm -