…test developers must use test platforms that comply with the Act. Again, what it will mean to comply is unclear. If the intention is that the current exemption for test…

…801 and 809)   Labs conducting LDTs for clinical investigations must comply with applicable investigational device requirements (e.g., 21 C.F.R. Part 812)   Stage 3 May 6, 2027 Compliance with…

…the parties in 2000.  In part, that order requires Lane Labs’ health-related marketing claims to be substantiated by competent and reliable scientific evidence.  The district court found that Lane Labs’…

At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot…

…competent and reliable evidence does not mean “uncontroverted proof” and denied the FTC’s motion. Whether this decision means that FTC may need to reconsider what constitutes “competent and reliable” scientific…

…Commerce Committee Oversight and Investigations Subcommittee sent a letter to the operators of the website Cafepharma.com (a self-proclaimed “site for drug reps by drug reps”) requesting information on anonymous postings…

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones…

…LDPs would use a methodology that “lends itself to inter-laboratory comparisons or proficiency testing.”  Low-risk tests, by contrast, would either be adjunctive in nature or protocols for which “the consequence…

…Safety Reports (HL7 ICSR) for submission of batch reports (high volume reporting).  Id. at 8834.  The eSubmitter software can be downloaded for free from FDA’s website.  The software generates an…

…claims unless such claims are substantiated by competent and reliable scientific evidence.  The FTC alleged that certain advertising claims subsequently made by GOL were not supported by “competent and reliable…

…multifaceted term is created. A test group means tests that have the following common elements: 1) the substance measured, 2) the type of specimen, 3) the test method, 4) the…

…– undoubtedly at significant expense to the company.  If this level of substantiation is viewed by the government in the future as a “floor” for “competent and reliable scientific evidence”…

…a one- to two-month supply of a drug cost-free where a new patient was experiencing reimbursement delays (see our blog post here). Another series of advisory opinions approved of free…

…collect evidence, catching unsuspecting companies by surprise. Given FDA’s increasing use of criminal search warrants, companies regulated by FDA should take precautionary steps to ensure that their business is prepared…

…There were a few presentations that included research and data on how consumers read disclosures online, and the innovative techniques that some companies are creating to effectively communicate disclosures (including…