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 …
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 …
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 …
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 …
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 …
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, …
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 …
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 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 FDA processes are streamlined, the medical device excise tax repealed, and the Senate is in the process of confirming a third Supreme Court nominee.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 …
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 …
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 …
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 …
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 …
From the start of the COVID-19 pandemic, access to accurate and reliable testing to identify patients exposed to SARS-CoV-2 or infected with COVID-19 was identified as a critical element of an effective public health response. Testing is needed to diagnose individuals with active symptoms, enable …
In a jaw-dropping move, HHS announced today that, effective immediately, FDA will no longer require premarket review of laboratory developed tests (LDTs)—including LDTs to detect the virus that causes COVID-19—absent notice and comment rulemaking. HHS is rescinding all guidance documents and informal statements of policy concerning …
