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      • What They Said – Press Releases 1st Quarter 2017
        Anyone who reads this blog knows that apparently I like to count things. Why? Well it provides the basis to confirm or refute general observations, and also can provide perspective that makes you stop and think and wonder. But if … Continue reading…
        - 15 days ago, 12 Apr 17, 11:18am -
      • DTC and OPDP
        It is a different era of enforcement. So far the first quarter of 2017 has not yielded a single regulatory action letter from the Office of Prescription Drug Promotion (OPDP). That said, in December of 2016 OPDP put out more … Continue reading →
        - 27 days ago, 31 Mar 17, 12:53pm -
      • 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 ……
        - 55 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…
        - 72 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 →
        - 84 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…
        - 85 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 →
        - 91 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…
        - 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 →
        - 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…
        - 15 Dec 16, 3:45pm -