• where experts go to learn about FDA
  • Year: 2020

    • Junior to Mid-Level Associate: Litigation/Internal InvestigationsMay 22nd, 2020

      Hyman, Phelps & McNamara, P.C. seeks to add a 1st to 4th year associate to its enforcement and litigation team.  Our team investigates and defends against threatened enforcement actions by government prosecutors and regulators, including the FDA and DEA.  Types of matters include: Representing clients in …

    • GAO report on Safety of Cell-Cultured Meat; Many Questions About Technology RemainMay 20th, 2020

      The U.S. Government Accountability Office (GAO) released a report titled “Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat.”  This report was requested by Rep. Rosa DeLauro (D-Conn.), and concerns the federal oversight of cell-cultured (or cell-based) meat, …

    • 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 …

    • If At First You Don’t Succeed, Bring Another Lawsuit: PMRS Takes a Loss in CourtMay 8th, 2020

      The Pharmaceutical Manufacturing Research Services (“PMRS”) appears to abide by the proverb “If at first you can’t succeed, try try again.”  After several denied Citizen Petitions, striking out in the Eastern District of Pennsylvania, and bringing then dismissing another suit against FDA in that same …

    • 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 …

    • Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack ThereofApril 28th, 2020

      We’re a little late to the party on this one (let’s just blame it on social distancing), but, after 10 years in the making, Transition Day has finally come and gone for protein products.  For the uninitiated, on March 23, 2020, all products approved as …

    • Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled SubstancesApril 24th, 2020

      A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its  Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled Substances” (Docket No. DEA-218, RIN 1117-AA61). The rule became effective June 1, 2010, and is …

    • HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good EnoughApril 23rd, 2020

      Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), manufacturers, distributors, and health care providers acting to address the COVID-19 crisis can be protected from products liability suits related to the use of certain products.  The Act provides immunity “from suit and liability under …

    • FDA’s Final Device Establishment Inspections Guidance Misses the MarkApril 23rd, 2020

      While it seems like all of FDA is consumed with responding to the current COVID-19 crisis, the agency is still managing to continue its work in other areas.  Earlier this week, FDA issued a final guidance, titled Nonbinding Feedback After Certain FDA Inspections of Device …

    • Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some LimitationsApril 22nd, 2020

      Last week FDA published a much needed guidance document addressing compounding by outsourcing facilities of shortage medications for patients confined to hospitals.  Yesterday FDA took an unprecedented step (see Section 503A guidance) and recognized, during the COVID emergency (or until FDA withdraws the policy), Section …

    • Court Vacates USDA Rule Citing APA ViolationsApril 20th, 2020

      Given the broad deference afforded to federal agencies, it is rare when a court overturns an agency action challenged under the Administrative Procedure Act (APA).  In a recent decision, however, a court found that a regulation issued by the U.S. Department of Agriculture (USDA) violated …

    • FDA Publishes “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency”April 17th, 2020

      FDA issued a much needed guidance document addressing compounding by outsourcing facilities for hospitalized patients during the COVID-19 emergency.  Like its other recent guidance documents addressing the COVID-19 pandemic, this guidance sets forth FDA’s temporary policy — for compounding certain drug products for hospitalized patients …