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  • COVID19

    • 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 FDA processes are streamlined, the medical device excise tax repealed, and the Senate is in the process of confirming a third Supreme Court nominee.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 …

    • FDA, Testing, and COVID-19: A “Mid-Mortem”August 25th, 2020

      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 …

    • HHS Reverses Its Position and No Longer Requires EUAs for COVID-19 LDTsAugust 20th, 2020

      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 …

    • Operation Warp Speed and the Standard for Review of the COVID-19 VaccinesAugust 11th, 2020

      On August 7th, FDA Commissioner Dr. Stephen Hahn, CBER Center Director Dr. Peter Marks, and FDA Deputy Commissioner Dr. Anand Shah published an article in the Journal of the American Medical Association (JAMA) outlining what the review standards would be for the COVID-19 vaccines currently …

    • FDA Clarifies Institutional Review Board Requirements for Reviewing Individual Access Requests for COVID-19 DrugsJune 9th, 2020

      FDA issued another COVID-related guidance for immediate implementation last week.  Citing a substantial increase in the number of requests for individual patient expanded access requests for COVID-19 investigational drugs (which we will use here to include biological products), on June 2, 2020, FDA released a …

    • New COVID-19 Guidances for Drugs and Biologics: FDA Provides Further Clarity on the Pre-IND Process and Clinical Trial ExpectationsMay 29th, 2020

      Two new guidances, both issued by FDA on May 11, 2020, focus on drugs and biological products proposed for use against COVID-19.  The first is entitled COVID-19 Public Health Emergency:  General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (the “Pre-IND …

    • COVID-19: It’s a Threat. And It’s MaterialMay 18th, 2020

      Now that most of the country has been in lockdown for about two months, everyone is undoubtedly aware that COVID-19 has been declared an “official” public health emergency.  In addition to the official declaration in January, HHS issued an additional and separate declaration – called …

    • FDA Law Alert – May 2020May 7th, 2020

      These are unsettling times as COVID-19 impacts our personal and professional lives, as well as those that we love.  During these unprecedented times, Hyman, Phelps & McNamara, P.C. is pleased to bring you the next installment of the FDA Law Alert.  This is the fifth …

    • Israeli COVID-19 Vaccine Developments Webinar – Wednesday, May 6, 2020May 5th, 2020

      On Wednesday, May 6, 2020, from 12:00pm-1:00pm (Eastern) the Maryland/Israel Development Center will hold a webinar, “Israeli COVID-19 Vaccine Developments.”  The event will discuss how Israel has mobilized its scientific and technological talents to address COVID-19, and will feature the following speakers: Yaky Yanai, CEO of …

    • Pricing in the Time of Price Gouging: Trying to Find a Safe HarborMay 5th, 2020

      As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money.  A lot of it.  When that happens, there are always immediate calls to prosecute individuals and companies for “price gouging” certain products and taking advantage of …

    • Swift Enforcement Against COVID FraudstersMay 1st, 2020

      Since HHS declared a public health emergency caused by COVID-19 in February 2020, there has been an overwhelming response to develop and market products to treat or mitigate the effects of the virus.  Unfortunately, bad apples still are out there preying upon consumer fears and …