• where experts go to learn about FDA
  • Month: April 2017

    • The Improving Access to Affordable Prescription Drugs Act: A Different Tack on ExclusivityApril 5th, 2017

      On March 29, 2017, Senator Al Franken (D-MN) and several other Senate Democrats introduced S. 771, the “Improving Access to Affordable Prescription Drugs Act.”  A companion bill, H.R. 1776, was introduced in the House on the same day by Representatives Jan Schakowsky (D-IL), Elijah Cummings …

    • Jury Rules on Charges against Owner and Head Pharmacist of NECCApril 4th, 2017

      On March 22, 2017, the jury rendered its verdict in the case of the United States v. Cadden, in the U.S. District Court for the District of Massachusetts (jury verdict form available here). The defendant, Barry J. Cadden, was the part owner and head pharmacist at …

    • Is it Scheduling or Rescheduling? DEA Issues Interim Rule on Oral Solutions of DronabinolApril 4th, 2017

      On March 23, 2017, DEA issued an Interim final rule “placing FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.” Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II, 82 Fed. Reg. …

    • Proposed Changes to the Device Intended Use RegulationApril 2nd, 2017

      Not long ago, we recommended that the Food and Drug Administration (FDA) begin a new rulemaking to update the intended use regulation. We promised a blog post to get the ball rolling with suggestions for improvement. The time has arrived. In the discussion below, the first …