As FDA continues to approve biosimilar drug products, and as sponsors participate – or rather choose not to participate – in the Biologics Price Competition and Innovation Act (“BPCIA”) version of the patent dance, more questions arise about the remedies reference product sponsors have when …
As you may have noticed, FDA recently unveiled a new website. As part of this redesign, FDA “enhanced” the Product-Specific Guidances (“PSG”) for Generic Drug Development web page. The “enhanced” version of the website includes new database and search function features, export features, and paginated …
Hi-Tech Pharmaceuticals, Inc. (Hi-Tech) and its President and Chief Operating Officer filed suit in the U.S. District Court for the District of Columbia to enjoin FDA from continuing to seek removal of DMHA products from commerce through the issuance of warning letters and “pressure… to …
A recent decision out of Pennsylvania caught our eye, not because it applied a new enforcement strategy by FDA, but to the contrary, because it relied on FDA’s “oldie but goodie” Inspection Warrant authority. Not a search warrant, which is subject to the same “probable …
The Department of Justice (“DOJ”) has been touting for years the common interest that government and industry share in promoting an ethical corporate culture. This week, DOJ reinforced the importance of a robust, well-designed, and effective corporate compliance program in DOJ’s determination of whether to …
Last week FDA issued a final guidance, Unique Device Identification: Convenience Kits, which clarifies FDA’s interpretation of a convenience kit for purposes of UDI labeling requirements. We previously blogged on the draft version here. As our readers know, the unique device identification system regulations require …
