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    • OHT-7’s Q1 2021 Report Card on EUA ReviewsApril 14th, 2021

      During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed: We have also really have ramped up our decisions. So we are currently over the last week averaging about nine …

    • Shhh! It’s a Secret! FDA is Not Providing Key Details in the EUA TemplatesApril 12th, 2021

      We have previously posted about the heartache and anxiety that is the EUA process (here).  Companies are waiting months for feedback from FDA and are frequently given comically short timelines for response. Another layer in this onion of poor management is the growing gap between the …

    • BARDA’s Mask Innovation Challenge – “I don’t pop in peach”April 6th, 2021

      On March 31st, 2021 BARDA launched a competition to design tomorrow’s mask. The Mask Innovation Challenge, at its core, is about finding new mask designs that can be mass produced at a low cost and provide general protections against respiratory pathogens. One of the lessons …

    • FDA Grants Marketing Authorization to BioFire’s Multiplexed COVID Test – Lines Have Been DrawnMarch 26th, 2021

      On March 17, 2021, FDA granted BioFire Diagnostics’ De Novo, making it the first COVID assay originally authorized on a temporary basis for this public health emergency to be given permanent access to the US market. While FDA has only released the signed letter affirming …

    • Pitfalls of the Notification Pathway – “I’m Sciencing as Fast as I Can”March 23rd, 2021

      On August 25th, 2020 Hyman, Phelps & McNamara, P.C. released a blog post covering experiences and lessons learned from our interactions with FDA and what was at the time the new and unfamiliar EUA pathway (FDA, Testing, and COVID-19: A “Mid-Mortem”). In the six months …

    • New CDRH EUA Doorbuster! Validate a Point-of-Care or Rx Home-Use Device and You Have a Chance to Walk Away with a Brand New OTC Claim!March 19th, 2021

      On March 16th, 2021 CDRH announced a major policy change for the EUA program in an effort to expedite screening testing for the pandemic. Screening is the testing of asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make …

    • The Biden Admin Announces Expansion of COVID Testing with New Funding – “Living in a Material World”March 17th, 2021

      On February 17th, 2021 the Biden Administration announced an expansion of the Federal strategy to test the population for SARS-CoV-2 with a three pronged approach: Expand COVID-19 testing for schools and underserved populations ($650 Million); Ramp up the domestic manufacturing of testing supplies and raw materials ($815 …

    • Beware EUA Deprioritization!February 25th, 2021

      As the end of the COVID pandemic appears into view, the Center for Devices and Radiological Health (CDRH) appears to be taking steps toward shedding at least part of its Emergency Use Authorization (EUA) caseload. Under Section 564(a)(1) of the Federal Food, Drug, and Cosmetic Act, …

    • When Will the Emergency End?January 11th, 2021

      It’s a burning question: when will we return to normal?  And although the answer is hugely subjective, this post focuses on the date the official emergency declaration for COVID-19 will terminate.  Despite the general sentiment that we want to be back to normal sooner rather …

    • The Future of EUAs: What Happens Post-CrisisDecember 7th, 2020

      Hyman, Phelps & McNamara, P.C.’s Anne Walsh will be presenting on The Future of EUAs: What Happens Post-Crisis, as part of this year’s Food and Drug Law Institute’s virtual Enforcement, Litigation, and Compliance Conference on December 15-16.  Hear from your peers about how they are staying …

    • The Potential Life Sciences Implications of the ElectionOctober 22nd, 2020

      The medtech industry has significantly changed during the Trump administration’s last four years. FDA processes are streamlined, the medical device excise tax repealed, and the Senate is in the process of confirming a third Supreme Court nominee. The industry also rapidly responded to the unprecedented …

    • Courts Reject Demands to Force FDA to Approve Hydroxychloroquine for COVID-19October 1st, 2020

      Two federal courts, in unrelated cases, separately rejected plaintiffs’ attempts to force FDA to authorize the use of hydroxychloroquine to treat or prevent COVID-19.  Hydroxychloroquine, a drug that has been used for over 60 years, has been touted by President Trump as an effective treatment …

    • 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 …

    • Shifting Patient Engagement in the Era of COVID-19: HPM Facilitates the First Four Virtual Externally-Led PFDD Meetings, Moderating the Fifth TodayAugust 28th, 2020

      We all have had to adapt to a world with COVID-19 concerns.  One of the challenges has been how to continue having Externally-Led Patient-Focused Drug Development (PFDD) meetings in these times of social distancing, travel restrictions, mask requirements, and other efforts to “flatten the curve”. On …