A recent proposed amendment to Minnesota’s Opiate Product Registration Fee appears intended to ensure continued availability of certain opiate products at hospitals. On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services …
This is the third in a series of posts on what DEA registrants can expect during cyclic and on-site inspections. Our series focuses on the background of such inspections, how investigators conduct them and how registrants should proactively prepare for and manage them. Part 1, …
On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices, which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices. This distinction can be critical, due to the significantly increased regulatory requirements that …
For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. This was …
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on, its critical Phase 3 study parameters: dose, eligibility criteria and endpoints, to name a few. …
On June 17, 2021, FDA gave notice of an upcoming public workshop focused on clinical trial designs for progressive multifocal leukoencephalopathy (PML). PML is a rare disease that occurs when the JC virus (JCV), generally thought to lie dormant in the adult population, takes advantage …
With the new Over-the-Counter (OTC) Monograph Reform came new facility fees (see our blog posts here and here, and FDA’s announcement here), and with new fees comes the new Arrears List. Facility fees under the OTC Monograph User Fee Act (OMUFA) were due for the …
In October 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published a Final Rule (which we summarized here) that implemented Section 804 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 384, to allow states and …
In our last post on Laboratory Developed Tests (LDTs), we suggested that Congress, not FDA, should lead in directing modernization of LDT regulation. Any change should be made by enacting new law, and not by Food and Drug Administration (FDA) administrative fiat. Coincidentally, on the same …
While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020, took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved …
Yesterday’s FDA approval of Biogen’s Alzheimer’s drug, Aduhelm (aducanumab-avwa), is historic and is of a magnitude that it may be harbinger for future Agency actions, especially in neuropsychiatric conditions. This has been a decision we’ve been closely following. So much so, in November, right after …
The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Hyman, Phelps & McNamara, P.C.’s Adrienne Lenz will be the speaker. This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination …
Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular Annual Conference. This year was no different. Recently, FDLI published on …
While federal efforts to address prescription drug prices are debated, states have continued to pursue their own measures that require drug manufacturers and other entities in the drug supply chain to disclose information about pricing. (See our previous coverage of such state laws here, here …
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 cicadas. These insects are so plentiful in local areas with trees, including FDA’s aptly named …
