By Andrew J. Hull* – Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for …
By Ricardo Carvajal – As directed under FSMA, FDA issued draft guidance on its approach to implementation of the Voluntary Qualified Importer Program (VQIP). In exchange for voluntarily subjecting themselves to an initial round of heightened scrutiny, importers who are approved for participation in the program …
By Jennifer D. Newberger – Devices intended to be reprocessed and used on more than one patient are required to be directly marked with a unique device identifier (UDI). 21 C.F.R. § 801.45. If, however, the direct marking “would interfere with the safety or effectiveness of the …
By Andrew J. Hull* - On June 22, three major pharmacists associations signed a letter to FDA asking the agency to use its enforcement discretion as pharmacies struggle to create appropriate product-tracing policies and practices before the July 1 compliance deadline under the Drug Supply Chain …
By Kurt R. Karst – We try our best to stay on top of the latest lawsuits against FDA, but every once in a while one gets past us without us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a …
By Jennifer D. Newberger – To further its efforts to balance risks and benefits with respect to approving medical devices through the premarket approval (PMA) pathway or utilizing the de novo classification process, FDA has now issued a draft guidance, "Factors to Consider When Making Benefit-Risk …
By Kurt R. Karst & Josephine M. Torrente – An article recently published in The BMJ (formerly known as the British Medical Journal), titled “Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study,” and …
By Jeffrey K. Shapiro – Last week, Senators Richard Burr and Al Franken introduced legislation aimed at easing the burdens of the Food and Drug Administration’s (FDA) review of devices. The bill is called “The FDA Device Accountability Act” (FDAA). A copy of the press …
By Jay W. Cormier, David C. Gibbons & Roger C. Thies – Having assisted clients with FDA inspections, 483 responses, and Warning Letter responses associated with cGMP for aseptic fill operations, we can imagine the nightmares many quality and manufacturing personnel would have with the observations …
By Kurt R. Karst – For months now we’ve been waiting patiently for anything out of the U.S. District Court for the District of Columbia with respect to the case that Veloxis Pharmaceuticals, Inc. (“Veloxis”) initially lodged against FDA in December 2014 (and then re-upped in …
By Ricardo Carvajal, Diane B. McColl & Jenifer R. Stach – FDA issued a declaratory order revoking the GRAS status of partially hydrogenated oils (PHOs), thereby finalizing its November 2013 tentative determination that there is no longer consensus among qualified experts that PHOs are safe for use in …
By John R. Fleder – When companies and individuals are “asked” (or told by a court) to pay money to FDA/DOJ as part of a resolution of a civil case, the sting of making the payment can be severe. A question many ask is, “Can we …
By Kurt R. Karst – The folks over at Inside Health Policy brought to our attention a recent article authored by Len M. Nichols, Ph.D., Director and Professor of Health Policy at the George Mason University Center for Health Policy Research & Ethics that we thought …
By Kurt R. Karst – Sometimes curiosity gets the better of us . . . . We take some bait and go down a rabbit hole. That’s what happened last week after FDA published a notice in the Federal Register announcing the Agency’s determination that Ondansetron …
By Riëtte van Laack – The California Organic Products Act (COPA) allows the use of the term “organic” on cosmetics only if they contain at least 70% organic ingredients. In a consumer class action, plaintiffs alleged that Hain Celestial Group Inc. (Hain) misleadingly labeled two of …
