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

    • HP&M is Pleased to Welcome Gail Javitt to the Firm as a DirectorJanuary 17th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Gail Javitt has become its newest Director.   Many leading companies have turned to Gail for her deep knowledge, skills, experience and thought leadership on the complex regulatory issues they face while looking to innovate …

    • FDA Says That Theranos Discovery Strain Is Causing Other FDA Enforcement Efforts to Take a BackseatJanuary 16th, 2020

      About eighteen months ago, the government accused former Theranos founder Elizabeth Holmes and former Theranos president Ramesh “Sunny” Balwani of wire fraud and conspiracy, a scheme that fooled investors into providing more than $700 million to the then-promising blood-testing startup. In the latest development in US …

    • The Vanishing PMA Device Advisory Panel MeetingJanuary 15th, 2020

      Under the Federal Food, Drug, and Cosmetic Act, FDA is authorized to hold advisory panel meetings for premarket approval applications (PMAs).  While FDA originally had to hold a panel meeting for all PMAs pursuant to the Medical Device Amendments of 1976, Congress liberalized the law …

    • HP&M Files Citizen Petition Challenging FDA’s Restrictions on Pharmacogenomic DataJanuary 14th, 2020

      Over the years, we have blogged many times on FDA’s approach towards laboratory-developed tests (LDTs) (see, e.g., prior posts here, here, here, here, and here).  On October 31, 2018, FDA issued a Safety Communication relating to one particular type of LDT: pharmacogenomic (PGx) assays.  On …

    • Cert-ainly Interesting Times for the FTC at the Supreme CourtJanuary 13th, 2020

      On December 19, 2019, the Federal Trade Commission (“FTC” or the “Agency”) filed a petition for writ of certiorari in the Supreme Court seeking review of a ruling by the Seventh Circuit case FTC v. Credit Bureau Center, LLC.  A detailed overview of the background …

    • HP&M Releases 2019 Enforcement BriefingJanuary 10th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading enforcement actions from 2019 that affect the FDA- and DEA-regulated industries.  As the largest boutique law firm dedicated to serving clients in this field, we are keenly aware of …

    • Fostering Oncology Product Development for Kids with CancerJanuary 9th, 2020

      Too often, children are not included in clinical trials for new drugs, even though children may eventually be prescribed those very same drugs. This forces physicians who treat children to try and extrapolate information collected from adult trials to determine if and how to use …

    • Just before the Compliance Date, FDA Issues Final Guidance on Serving Size-Related and Miscellaneous Issues Regarding the “New” Nutrition Labeling RegulationsJanuary 6th, 2020

      As we previously reported, in 2016, FDA issued significantly revised nutrition labeling regulations for foods and dietary supplements.  The compliance date is January 1, 2020 for all entities except those with less than 10 million dollars in annual sales. The updated regulations resulted in many questions …

    • PhRMA Challenges Oregon Drug Pricing Transparency LawsJanuary 2nd, 2020

      On December 9, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a civil action in the United States District Court for the District of Oregon seeking declaratory and injunctive relief against the Acting Director of the Oregon Department of Consumer and Business Services …