At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. Some of us might still recall the 2017 salmonella outbreak linked to raw turkey products that caused over 279 infections, …
As was introduced in our recent blog post summarizing the 2022 MedTech conference (here), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot (see announcement attributed …
FTC sure thinks so. And the FTC said as much in a recent Amicus Brief (“Brief”) in paragraph IV litigation between Avadel CNS Pharmaceuticals (“Avadel”) and Jazz Pharmaceuticals Inc. (“Jazz”). This type of statement from the FTC is unprecedented; not only is the FTC Brief …
FDA announced that it has completed the first pre-market consultation for an animal cell-cultured food, based on a safety assessment submitted by UPSIDE Foods. In an indication of the significance of this development, FDA Commissioner Robert Califf and CFSAN Director Susan Mayne issued a statement …
Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that John W.M. Claud has joined the firm as Counsel. Mr. Claud is a 15-year veteran of the Department of Justice, where most recently he was an Assistant Director of the Consumer Protection Branch overseeing …
In our last blog post, we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program. User Fees User …
Early Nov. 2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The draft guidance provides information regarding various aspects of the OMUFA program under sections 744L and 744M of the FDC Act, as added by the …
When you have followed Drug Enforcement Administration (“DEA”)/Department of Justice (“DOJ”) civil settlements for as long as we have, you cannot help but think that you’ve seen it all. Then something novel comes along. Unlike virtually all DEA/DOJ civil settlements that we are aware of, …
On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”). In addition to reauthorizing for an additional five fiscal years—Fiscal Years 2023-2027—several …
At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF) The IMDRF conference was …
On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. For a summary of the rule, we refer readers to our July 2022 post …
We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. Now, after an unfavorable HHS Office of the Inspector …
On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” Panelists discussed CMC challenges for CART therapies, including potency assay development, analytical method transfer, and demonstrating comparability. …
FDA began the Software Precertification (Pre-Cert) pilot program in 2017 to evaluate an alternative approach to regulation of software as a medical device (SaMD) over the total product lifecycle (TPLC). We have followed it over the last five years, with blog posts here, here, here, …
On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance …
