Device Attorney HP&M seeks to add an associate to its thriving device practice. We assist medical device manufacturers with product development, FDA approval and clearance, and post-market compliance. Qualified candidates should have familiarity with premarket strategies, including: Investigation Device Exemption requirements Premarket Notifications (510(k) clearances) Premarket Approval Applications …
For those of us of “a certain age,” the original “Sesame Street” recalls fond memories: Mr. Hooper, Mr. Snuffleupagus (when only Big Bird could see Snuffy), and those catchy songs like “C Is For Cookie” and, of course, “Pinball Countdown” – those animated segments with …
No, “Tick Tock, Goes The Clock” is not a reference to Doctor Who poetry, Ke$ha (TiK ToK), or to that “TikTok” destination for mobile videos that’s been in the news recently. We’re talking about the countdown to October 1, 2020, when the Fiscal Year 2021 …
The American Conference Institute (“ACI”) is sponsoring its 14th Annual Paragraph IV Disputes Conference on October 6 – 7, 2020 (Eastern Daylight Time). Like a lot of conferences this year, the ACI conference format has changed from a live, in-person event to an interactive, virtual conference. ACI’s Paragraph …
On August 19, the Department of Health and Human Services (HHS) announced that FDA shall no longer conduct premarket review of laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act and implementing regulations (FDCA). The crux of the statement is this: “the …
We all have had to adapt to a world with COVID-19 concerns. One of the challenges has been how to continue having Externally-Led Patient-Focused Drug Development (PFDD) meetings in these times of social distancing, travel restrictions, mask requirements, and other efforts to “flatten the curve”. On …
Every so often, FDA revisits a policy set forth in FDA’s Manual of Policy and Procedures (“MAPP”) to reflect the Agency’s current practices. Though MAPPs really only govern the actions of the Agency, their content is important to understanding how FDA will approach certain requests. …
From the start of the COVID-19 pandemic, access to accurate and reliable testing to identify patients exposed to SARS-CoV-2 or infected with COVID-19 was identified as a critical element of an effective public health response. Testing is needed to diagnose individuals with active symptoms, enable …
On July 27, 2020, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (“Plaintiffs”) filed a complaint against USDA challenging the final “BE labeling rule,” i.e., the final rule implementing …
Owners and management of the Kilgoban Drug Company, a fictional prescription drug wholesaler in the fictional U.S. state of Moosissippi, are preparing to begin operations. They have applied for and obtained all of the licenses required to operate their business, including a wholesaler license issued …
In a jaw-dropping move, HHS announced today that, effective immediately, FDA will no longer require premarket review of laboratory developed tests (LDTs)—including LDTs to detect the virus that causes COVID-19—absent notice and comment rulemaking. HHS is rescinding all guidance documents and informal statements of policy concerning …
Earlier this week, FDA was supposed to issue proposed rules—years in the making—implementing over-the-counter (OTC) hearing aid rules, as required by the Food and Drug Administration Reauthorization Act (FDARA) (read HPM’s summary here). Under FDARA, FDA is required to issue proposed rules three years from …
“Here’s a rule of thumb; too clever is dumb.” Unfortunately, eight people didn’t follow Ogden Nash’s rule of thumb and are now facing a 19-count criminal indictment for falsifying records of clinical trials of investigational drugs and lying about it to FDA. The 60-page indictment was …
On July 23, FSIS acknowledged that it had received a Petition from the Harvard Law School’s Animal Law and Policy Clinic (Harvard or Petitioner) regarding the naming of cell-based or cultured meat and poultry products. Petitioner requests that the Food Safety Inspection Service (FSIS) of …
On August 7th, FDA Commissioner Dr. Stephen Hahn, CBER Center Director Dr. Peter Marks, and FDA Deputy Commissioner Dr. Anand Shah published an article in the Journal of the American Medical Association (JAMA) outlining what the review standards would be for the COVID-19 vaccines currently …
