• where experts go to learn about FDA
  • Month: September 2020

    • FDA Launches Digital Health Center of ExcellenceSeptember 25th, 2020

      On September 22, FDA announced the creation of a Digital Health Center of Excellence (DHCoE), which has grown out of their existing Digital Health Program.  The objectives of the DHCoE include connecting and building partnerships, sharing knowledge and innovating regulatory approaches related to digital health.  …

    • Final Decision on Economic Analysis Report of Organic Livestock and Poultry Practices Rule and Summary of Comments on the Economic Analysis Report; The Lawsuit ContinuesSeptember 24th, 2020

      Quite some time ago, we blogged on the organic livestock and poultry practice (OLPP) rule.  The rule established minimum indoor and outdoor space requirements for chickens based on the type of production and stage of life, as well as added new provisions for livestock handling …

    • A Couple of Firsts in Food EnforcementSeptember 22nd, 2020

      Last week brought a reminder that the government can bring to bear a range of legal theories – some old, some new – in pursuing alleged violations of food safety requirements. The U.S. Department of Justice (DOJ) announced a sentence levying $17.25 million in criminal penalties …

    • FDA Pre-Cert Program Update – Good Progress but Full Launch Not Yet in SightSeptember 18th, 2020

      FDA’s Software Pre-Certification (Pre-Cert) Program is intended to create a new streamlined regulatory process for software as a medical device (SaMD) (see our earlier blog posts on the program here, here, here, here, and here).  On September 14, 2020, FDA updated the Digital Health Software …

    • New York Opioid Stewardship Act: Take 2 from the Second CircuitSeptember 16th, 2020

      On Monday, September 14, the United States Court of Appeals for the Second Circuit reversed the December 2018 opinion from the United States District Court for the Southern District of New York that invalidated the New York Opioid Stewardship Act (OSA).  In Association for Accessible …

    • Californovation? California is Set to Become a Drug ManufacturerSeptember 16th, 2020

      Californovation (sung to the tune of the Red Hot Chili Peppers’ Californication, obviously): the new portmanteau seems appropriate for California, who just keeps coming up with new ideas to address the many hurdles consumers face with respect to access to affordable medicines.  Last year, we …

    • Trump Embraces International Reference Pricing in Executive OrderSeptember 15th, 2020

      As we reported in a previous post, Donald Trump several weeks ago threatened drug manufacturers with the prospect of an Executive Order mandating international reference price limitations, unless the manufacturers put forward proposals to significantly reduce drug prices by August 24.  On Sunday, September 13, …

    • How to Stay In Touch With Your Customers During the Coronavirus PandemicSeptember 14th, 2020

      On Tuesday, September 15, at 8:00 am, Hyman,Phelps & McNamara, P.C. Director Gail Javitt will moderate a one hour webinar sponsored by the Maryland Israel Development Center (MIDC), titled “How to Stay In Touch With Your Customers During the Coronavirus Pandemic.”  The webinar will feature …

    • FDA Law Alert – September 2020September 10th, 2020

      During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on regulatory and …

    • Regulation and Utilization of Digital Health in Clinical TrialsSeptember 9th, 2020

      Hyman, Phelps & McNamara, P.C. Director Jeff Shapiro will be moderating “Digital Health Session 1: Bonus Session – Regulation and Utilization of Digital Health in Clinical Trials” as part of the Food and Drug Law Institute’s Digital Health Conference on September 10.  Jeff’s panel will …

    • CDRH Issues Draft Guidance Regarding Patient Reported OutcomesSeptember 8th, 2020

      In recent years, FDA has sought to increase the patient perspective in its regulatory decision making.  One way this is accomplished is through use of patient‑reported outcome (PRO) measures in clinical studies.  PROs can assess concepts that are unobservable to clinicians and are only know …

    • Join Our Team: Hyman, Phelps & McNamara, P.C. Seeks Device and Drug Development AttorneysSeptember 4th, 2020

      Device Attorney HP&M seeks to add an associate to its thriving device practice.  We assist medical device manufacturers with product development, FDA approval and clearance, and post-market compliance.  Qualified candidates should have familiarity with premarket strategies, including: Investigation Device Exemption requirements Premarket Notifications (510(k) clearances) Premarket Approval Applications …

    • PTE Countdown (Or Not?!?): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 (Read to a Funky Soundtrack and Vocals by The Pointer Sisters)September 3rd, 2020

      For those of us of “a certain age,” the original “Sesame Street” recalls fond memories: Mr. Hooper, Mr. Snuffleupagus (when only Big Bird could see Snuffy), and those catchy songs like “C Is For Cookie” and, of course, “Pinball Countdown” – those animated segments with …

    • Tick Tock, Goes The Clock . . . October 1st is Fast-ApproachingSeptember 2nd, 2020

      No, “Tick Tock, Goes The Clock” is not a reference to Doctor Who poetry, Ke$ha (TiK ToK), or to that “TikTok” destination for mobile videos that’s been in the news recently.  We’re talking about the countdown to October 1, 2020, when the Fiscal Year 2021 …

    • ACI’s 14th Annual Paragraph IV Disputes (Virtual Conference)September 2nd, 2020

      The American Conference Institute (“ACI”) is sponsoring its 14th Annual Paragraph IV Disputes Conference on October 6 – 7, 2020 (Eastern Daylight Time).  Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph …