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A Final LDT Rule in April!? Will FDA be Prepared?
…[17] FDA, News Release, FDA unveils a streamlined path for the authorization of tumor profiling tests alongside its latest product action (Nov. 15, 2017), https://www.fda.gov/news-events/press-announcements/fda-unveils-streamlined-path-authorization-tumor-profiling-tests-alongside-its-latest-product-action. [18] Compare FDA, Current List…
District Court Interprets EKRA
…18, 2021) A. Background Facts S&G Labs Hawaii, LLC (“S&G Labs”) is a Hawaiian laboratory company that performs various lab testing services including toxicology (for both legal and illicit substances)…
Bad Labs! Bad Labs? Whatcha Gonna Do?
…electrical safety, electromagnetic compatibility, software, cybersecurity, human factors, and performance (which includes bench, animal, and clinical tests). Given this, it is common for firms to contract with independent labs (“third-party…
ACI’s 5th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA
…training on the 1984 Hatch-Waxman and the 2010 Biologics Price Competition and Innovation Act (BPCIA). ACI’s Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA is a three-week virtual…
Two New Draft Guidances Outline FDA’s Proposed Approach to Regulatory Oversight of Next Generation Sequencing Diagnostic Tests
…genome testing, risk prediction, cell-free DNA testing, fetal testing, pre-implantation embryo testing, tumor genome sequencing, RNA sequencing, or use as companion diagnostics. In other words, the proposal covers only a…
ACI’s 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA – October 10-26, 2023 (Virtual)
…Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA! Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series from October 10-26, a virtual three-week program designed to provide new lawyers and…
FDA Finalizes Guidance on Non-Clinical Bench Performance Testing Information in Premarket Submissions
…and summary table (optional). Complete test reports should include: test performed; objective of the test; description of test methods (test sample information, test sample size/selection, test methods); pass/fail criteria; data…
CDRH Issues Draft Guidance Regarding Test Reports for Nonclinical Bench Studies in Premarket Submissions
…checklist, which for 510(k)s states that for each performance test a sponsor must include a “full test report . . . for each completed test. A full test report includes:…
ACI’s 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA – October 8-24, 2024 (Virtual)
The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024. This virtual three-week program is…
Tuesdays (and Thursdays) With Regulations.gov BETA
…to create quick daily docket sheets. Here are example URLs: “https://beta.regulations.gov/search?agencyIds=FDA&postedDateFrom=06-09-2020&postedDateTo=06-10-2020&sortBy=title&sortDirection=desc” (for documents) and “https://beta.regulations.gov/search/comment?agencyIds=FDA&postedDateFrom=06-09-2020&postedDateTo=06-10-2020&sortBy=postedDate&sortDirection=desc” (for comments). These URLs search FDA docket entries on the Beta site from June 9,…
Court Denies FTC Motion to Hold Lane Labs in Contempt
…hired a compliance officer to insure that the company remained in compliance with the consent decree. Lane Labs also offered two experts who testified that the company had competent and…
FDA, Testing, and COVID-19: A “Mid-Mortem”
…As FDA regulatory practitioners who have worked with multiple companies trying to introduce COVID-19 tests, we have witnessed first-hand both the challenges faced by companies seeking to bring new tests…
Court Blesses FDA’s Rarely Used Administrative Search Warrant Authority
…company to speak with investigators on the ground that the warrant did not affirmatively require the company to engage in testimonial conduct, just the seizure of records. Thus, the court…
Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two)
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
Caronia Webinar – Slides and Audio Available for Download
…HP&M was quite pleased that hundreds of sites participated in the webinar. The audio link is now available (here), and the slides can be downloaded from the HP&M website (here)….