…multi-million dollar figures paid by other healthcare companies. Or maybe the civil settlement escaped notice because the criminal component was more interesting. Although not the subject of this blog post,…

…FDC Act § 505(j)(5)(D)(i)(I)(bb) permits a “mix-and-match” approach in addition to an “all-in-one” approach. Under the “all-in-one” approach, the parenthetical “(which other applicant has received tentative approval)” provides that the…

…Although FDA and USDA-FSIS are the two federal agencies that generally regulate mandatory labeling requirements for foods, the bill gives the USDA Agricultural Marketing Service (AMS) the responsibility for establishing…

…Covered Entities may pursue “mutually agreed-upon alternative refund arrangements,” such as netting, crediting, or forgiving de minimus or insignificant overcharges. 82 Fed. Reg. 1218, 1220. Manufacturer Civil Monetary Penalties The…

…nearly all references to “essential clinical performance” to “patient harm.” This change appears to shift the way in which FDA plans to evaluate cybersecurity risk—from essential clinical performance to the…

Change is inevitable (cue David Bowie’s “Changes”). Sometimes change occurs slowly and goes (largely) unnoticed, and sometimes it comes fast and unexpected. Sometimes change is good, and sometimes it’s not….

…the agency’s goals. Also, participation contributes to improving quality monitoring. FDA also suggests that such public information might be useful to pharma when selecting contract manufacturers and component suppliers, and…

…avoid having the rule being overturned by Congress under the Congressional Review Act. Of course, if a new administration takes over next year, the rule’s future would be questionable, even…

…line with the current Dietary Guidelines. In the Sept. 27 announcements, FDA acknowledges that the regulation for “healthy” as a nutrient content claim is in need of an update. Since…

…could significantly affect safety or effectiveness. While there is a linkage between that question and risk assessments, the two approaches are not identical. The draft guidance also includes a discussion…

…doubles down on the Agency’s newfound position.  At this juncture, FDA has determined that [the] Stipulation for Dismissal [in Hoffmann-La Roche, Inc. v. Richardson, et. al] is the controlling legal…

…21 C.F.R. Part 101.  In addition, the resources include separate tables of the reference values and some other information that is included in the final rules. FDA provided responses to…

…experience handling controlled substances in a lawful manner and whether the applicant has engaged in illegal activity involving controlled substances. In this context, DEA stated that illegal activity incudes any…

…formal designation, it must then submit a formal RFD and await a formal Letter of Designation—another 60 days. And if it wants to appeal to the Office of Special Medical…

…misbranded devices into interstate commerce. Before trial, the government dropped the adulteration charges, leaving only the misbranding charges related to the company’s failure to have a 510(k) clearance for the…