…of a problem.  The latest efforts by Rep. Markey and Senator Merkley continue to search for a chimera: badly designed devices, cleared through the 510(k) process, regularly causing death and…

…high-complexity CLIA certified laboratories. This updated guidance extended the policy to commercial test kit manufacturers and distributors, who now may begin distribution of a test kit prior to submission of…

…pass-through prohibition, were challenged in three lawsuits brought by industry trade associations and an opioid manufacturer. The plaintiffs argued that the pass-through prohibition violated the dormant Commerce Clause, which prohibits…

…you should test again 48 hours later. If the second test is negative, you should test again 48 hours after the second test. If the third test is negative, you…

…Safety Reports (HL7 ICSR) via AS2 (for high volume reporting) or by using FDA’s eSubmitter software (for low volume reporting). The HL7 ICSR option extracts information directly from the reporter’s…

…OPEN ACT will incentivize drug makers and innovators to ‘repurpose’ major market drugs for life-threatening rare diseases and pediatric cancers, which opens the door to the development of hundreds of…

…foods.  Id. at 46673 (footnote omitted).   Because the proposed rule’s definition of “gluten-free” would permit foods not completely free of gluten to bear the claim, FDA seeks comments on whether…

…the test samples. It appeared to many that the issue was not the tests but the panel. Apparently, there are tests with perfectly good performance that, for some reason or…

Advisory Opinion No. 08-04 (Free Trial Program) Last week, the Office of Inspector General (“OIG”) of the Department of Health and Human Services posted an advisory opinion addressing a free…

…version of the website includes new database and search function features, export features, and paginated search results. The new search functions will allow users to perform text searches of PSGs…

By Carrie S. Martin – FDA just released the Warning Letter it issued to Novartis Pharmaceuticals Corporation (“Novartis”) in April regarding two purportedly unbranded websites, www.gistalliance.com and www.cmlalliance.com (the “alliance…

…page 15: The use of samples previously tested positive by another EUA RT-PCR assay may be acceptable without additional comparator testing. You should indicate the source of the samples, provide…

…tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS‑CoV‑2 infection. The tests are similar to a pregnancy test…

…law that governs laboratory testing. Among other elements, CLIA requires that tests be performed in appropriately certified laboratories, unless the test is categorized as “waived.” High-complexity tests can only be…

…of the Lucira OTC home test for influenza and COVID-19 as “underscor[ing] the Agency’s continued commitment to increase availability of accurate and reliable at-home diagnostic tests” (April 2023 FDA Update…