…the practitioner had not alleged “evidence to show why he can be entrusted with a registration nor raised any contention that he acknowledges his misconduct and has undertaken remedial measures,”…

…See Jeff Shuren & William Maisel, Looking Ahead to 2022 as FDA’s Center for Devices and Radiological Health Manages a Sustained Increase in Workload, FDA Voices (Dec. 21, 2021), https://www.fda.gov/news-events/fda-voices/looking-ahead-2022-fdas-center-devices-and-radiological-health-manages-sustained-increase-workload….

…United States ex rel. Ibanez v. Bristol-Myers Squibb Co., affirmed the district court’s dismissal of relators’ (the government declined to intervene) second amended complaint and denial of relators’ motion to…

…specific study design, results reporting, and statistical guidance for qualitative, quantitative, and semi-quantitative tests. The guidance also provides general design considerations regarding testing sites, study participants, subjects/samples, financial disclosures, and…

Last month, the U.S. Court of Appeals for the Eleventh Circuit affirmed prison sentences for Stewart and Michael Parnell, and Mary Wilkerson, formerly of the Peanut Corporation of America (PCA)….

By Jeffrey K. Shapiro – This post is the second in an occasional series that will examine significant or interesting warning letters involving medical device companies.  As a reminder, FDA…

Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to…

…person. Relevant information and links follow. Click here to VIEW AGENDA. Click here for In-Person Registration or Live Stream Registration Refer questions to VDAT@dea.gov with subject line “Supply Chain Conference.”…

…scene changes, busy scenes, and large-moving superimposed text along with other competing modalities such as the strong, fast-moving musical beat. In contrast, the risk information is in a small window…

…FDA cites “typography, layout, contrast, headlines, paragraphing, white space, and other techniques” as affecting readability and emphasis. FDA also highlights that “risk information is relegated farther down in paragraph format…

…carefully. Of course, it is not that easy to assess this risk, especially when FDA institutes deprioritization based on changing market conditions. Also, not all product categories are treated the…

…‘Point-of-Care’ and ‘OTC Home Use’ are substantial. Devices authorized for Point-of-Care are not validated to the same degree with respect to Robustness (Flex Studies), Human Factors (Human Usability), the data…

…exceeding a limit of $75,000 for a single person plus $25,000 for each additional person. While patients with any government or commercial insurance are eligible for the free drug program,…

…experiences. In addition, cigar products may also contain various non-tobacco ingredients that the manufacturer uses primarily or exclusively for non-flavoring purposes (e.g., humectants, preservatives, adhesives), but could nonetheless affect the…

As has been widely covered in local and national press in and around the Washington, DC area, this month marks the once every seventeen year emergence of the Brood X…