As we discussed last summer, FDA has recognized that negotiations surrounding the development of a Single, Shared System REMS may fail, and, to that end, issued a guidance detailing the Agency’s waivers process. Now, the market has borne the fruits of that labor in the …
“Don’t test me!”— that’s a warning that I, along with my younger brother, Erik, heard more than once from our parents while growing up. The warning would come up from time to time—but particularly during our teenage years—when teenagers do what they sometimes do: challenge …
The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues: Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hyman, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair. The conference will be held in South …
On March 25, 2019, FDA issued a draft guidance, “Rare Diseases: Natural History Studies for Drug Development,” to help inform the design and implementation of natural history studies that can be used to support the development of drugs and biological products for rare diseases (hereinafter …
Okay, okay . . . . It’s now a month after Rare Disease Day (on which Hyman, Phelps & McNamara, P.C.’s own Frank J. Sasinowski took part in some of the festivities). We’re a little late this year in pulling together and posting on the …
The “Petitioned ANDA”—It’s a route to ANDA approval that’s been around since even before the enactment of the 1984 Hatch-Waxman Amendments. For several years after the enactment of Hatch-Waxman, the petitioned ANDA was a mainstay of the generic drug industry’s drug development paradigm. And although …
Spring is here! How do we know? Is it the cherry blossoms starting to bloom in Washington, DC? Is it the daffodils emerging from hibernation? No – we know it’s Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around …
We posted last year about the dispute over FDA’s determination to include certain nominated substances on its Bulk Substances List 1 for Section 503B outsourcing facilities. Recall that in 2017, after FDA approved Endo/Par’s Vasostrict® finished drug product, several entities nominated active pharmaceutical ingredient vasopressin …
On March 16, 2019, Advances in Therapy published a commentary authored by HP&M Attorney James E. Valentine along with co-authors Marielle Contesse, Tracy Wall, and Mindy Leffler. The paper sets forth the case, and provides a methodologic overview, for incorporating qualitative patient and caregiver video …
About 6 weeks after Vanda filed its complaint, the company’s lawsuit has joined its clinical trial: on hold. Last week, the District Court of D.C. granted FDA’s motion for a voluntary remand of the case challenging FDA’s requirement to perform 9-month large animal studies prior …
FDA recently issued a draft guidance document, Nonbinding Feedback After Certain FDA Inspections of Device Establishments, which outlines the process for obtaining FDA feedback on proposed remedial actions in response to observations issued on a Form 483, the Agency’s Inspectional Observations Form, following an inspection. Background Section …
After years of talk about replacing the antiquated, carbon-leaved triplicate Official Order Form (“DEA Form 222” or “DEA-222s”) required for schedule I and II controlled substance transfers, the Drug Enforcement Administration (“DEA”) is proposing to implement a single-sheet order form. New Single-Sheet Format for U.S. …
An Implanted Brain Computer Interface (BCI) device may sound like something out of science fiction, but FDA apparently believes these devices are on their way to becoming a reality. FDA recently released a draft guidance document that provides recommendations on how to gain approval to …
Ok, Tom, I think I can name that biosimilar in four letters! Added on to the suffix! And let’s make it interesting: it’s an interchangeable. As a follow-up to its 2017 Guidance for Industry: Nonproprietary Naming of Biological Products, FDA issued a new draft guidance filling …
As readers of this blog may recall, the issue of the regulation of meat and poultry derived from cell lines, identified by such terms as cultured meat, clean meat, and cell-based meat, became front cover news a little more than a year ago when the …
