On Monday, March 4, 2019, FDA released its Final Guidance , titled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” We blogged about FDA’s draft guidance here, which FDA published about a …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …
On March 5, Scott Gottlieb, M.D., announced he will be stepping down as Commissioner of FDA. His resignation will become effective in about one month. His two-year tenure, since May 2017, has been very productive. Gottlieb spearheaded initiatives on a variety of complex issues, including …
On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here). The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such …
On February 21, the U.S. Court of Appeals for the Second Circuit issued a summary order reversing the dismissal by the District Court of the Southern District Court of New York of an action by FTC and New York State (“FTC”) action challenging the marketing …
On Tuesday, February 19, 2019, FDA released its first Final Rule (of many likely to follow…) identifying six substances that FDA has determined are appropriate for use in compounding by Section 503A pharmacies. The Final Rule relates back to FDA’s 2016 Proposed Rule nominating certain …
After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made …
Back in 2014, The Sunscreen Innovation Act (“SIA”) amended the Federal Food, Drug, and Cosmetic Act with the goal of accelerating the review of sunscreen ingredients that had been proposed for addition to the sunscreen monograph. Although the original focus of the SIA was on …
They could have taken a middle ground, given the unique facts of FTC v. Shire ViroPharma — but instead the Third Circuit went whole hog with a decision that, if it stands, could set the FTC’s litigation authority back decades. In this case, bad facts …
As difficult as it might be to believe, its true. In fact, last week, the FDA Commissioner, Dr. Scott Gottlieb, and the CBER Center Director, Dr. Peter Marks, issued a press release cautioning consumers against receiving “young donor plasma infusions” that are promoted as unproven …
Hyman, Phelps & McNamara, P.C. (HP&M) is proud to announce that two associates, Serra Schlanger and Rachael Hunt, will be hosting a program on telemedicine for FDLI’s New to Food and Drug Law Group (NFDL). Telemedicine: Key Issues to Consider When Advising Clients, will take place …
The United States Department of Justice (“DOJ”) announced on February 8, 2019, the use of a new weapon in its enforcement arsenal to help manage the opioid crisis. It involved a coordinated effort including DOJ’s Prescription Interdiction & Litigation (“PIL”) Task Force, which deploys all …
As avowed dog-lovers and FDA law enthusiasts, a recent Complaint filed in the District Court of D.C. caught our attention. Vanda Pharmaceuticals filed a Complaint on February 6, 2019 alleging that FDA’s insistence that Vanda perform a 9-month dog study with its drug candidate tradipitant …
You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change …
Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago. At the same time, these medical devices can pose risks …
