• where experts go to learn about FDA
    • HRSA: No Further Delay of 340B Ceiling Price and Civil Monetary Penalties RuleNovember 30th, 2018

      On November 6, we reported that the Health Resources and Services Administration of the Department of Health and Human Services (HHS) had proposed to move up the effective date of its 340B program ceiling price and civil monetary penalties regulation from July 1 to January …

    • FDA Requests Input on Consumer Survey Regarding Allergens in CosmeticsNovember 30th, 2018

      On November 7, the FDA announced that it is seeking approval for a web-based pilot survey about allergens in cosmetics, including fragrances, hair products, makeup, nail products and skin care products.  The federal register notice was published on Nov. 8, 2018. The survey is part of …

    • FDA Relaxes UDI Compliance Deadlines in New Guidance DocumentNovember 29th, 2018

      On November 5, 2018, FDA issued its latest UDI policy “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” deferring enforcement of direct marking deadlines. The new guidance, effective immediately, supersedes the guidance issued in …

    • International Plan of Mystery: ICH Guidelines for Generic DrugsNovember 28th, 2018

      Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common global standards for generic drugs. This proposal is yet another strategy in Commissioner Gottlieb’s Drug …

    • Possible Major Changes to 510(k) Program AheadNovember 26th, 2018

      The 510(k) pathway was first established in the Medical Device Amendments of 1976, and amended in the Safe Medical Devices Act of 1990. Since that time, the statutory language creating this pathway has remained largely unchanged. Yet, the program has morphed from one in which …

    • HP&M to Speak at Next Week’s FDLI Conference on the Drug Quality and Security Act, Titles I and II – A “Not-to-Miss Event!”November 26th, 2018

      On Tuesday December 4th, the Food & Drug Law Institute will hold a conference in Washington, D.C., on current issues surrounding implementation of Titles I (the Compounding Quality Act) and II (the Drug Supply Chain Security Act) of the Drug Quality and Security Act (DQSA). …

    • FDA on Gene-Edited Plants and Animals: “We’ve Got This”November 25th, 2018

      To the possible chagrin of those who think that FDA lacks jurisdiction over gene-editing of plants and animals, the Agency announced a Plant and Animal Biotechnology Innovation Action Plan that lays out actions the Agency is taking to help harness the potential benefits of the …

    • Pharmacogenetic Tests: Recent FDA Authorization for One and Warnings about OthersNovember 21st, 2018

      On October 31, 2018, FDA announced that 23andMe could market its Personal Genome Service Pharmacogenetic Reports test (the “23andMe test”) as a direct-to-consumer test for providing information about genetic variants that may be associated with medication metabolism.  The 23andMe test was reviewed using the de …

    • Is Your 510(k) Device a Combination Product?November 19th, 2018

      Earlier this year, FDA quietly made changes to their 510(k) clearance letters related to combination products cleared via the 510(k) pathway. The letters now include the following language (new text in bold italics): Although this letter refers to your product as a device, please be aware …

    • HP&M Snags Another Award: LMG Life SciencesNovember 16th, 2018

      As 2018 winds down, awards season is in full swing! Last week we announced that Hyman, Phelps & McNamara, P.C. (“HP&M”) was tapped by U.S. News and Best Lawyers as the recipient of the 2019 “Law Firm of the Year in FDA Law” award.  This …

    • FDA Proposed Rule Allows Waiver of Informed Consent If IRB Finds Risk Is MinimalNovember 15th, 2018

      The informed consent requirements in drug and device trials are important for subject protection. But there are trials where it is not possible (or difficult) to obtain consent, and the risk to subjects is minimal. Until recently, these trials could not go forward. In the 21st …

    • Crazy Kind of ClaimsNovember 14th, 2018

      Once in a while a consumer class action catches our particular attention.  Most recently, Kind LLC was sued in the U.S. District Court for the Eastern District of New York over its advertising, labels, and ingredient statements for its “Pressed by KIND” and “KIND Fruit …

    • More Kryptonite for KratomNovember 13th, 2018

      Most people think of getting salt water taffy from resort beach town Myrtle Beach, SC. But, apparently, there is more activity going on in Myrtle Beach: a company there was supplying customers with kratom, a substance that the government contends is an illegal dietary supplement. …

    • HP&M to Co-Host “DEA Compliance During the Opioid Epidemic” WebinarNovember 12th, 2018

      Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018 (3:00-4:00 PM ET) and is geared especially towards DEA-registered manufacturers, distributors, importers, exporters and practitioners. The …

    • FDA Finalizes One Guidance and Issues a Draft Guidance Related to the Amended Nutrition Labeling RegulationsNovember 12th, 2018

      Last week FDA published a final guidance and a draft guidance related to the nutrition labeling regulation amendments published in 2016. Final guidance The Guidance, titled “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of …