Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
On July 25, 2025, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2024/2025 for the Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more
On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more
On July 12, 2024, the FDA provided small dispensers—those employing 25 or fewer full-time pharmacists or pharmacy technicians—with an exemption from the Drug Supply Chain Security Act’s (“DSCSA”) enhanced drug distribution...more
On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more
The recent Supreme Court decisions of SEC v. Jarkesy and Loper Bright Enterprises v. Raimondo have the potential to meaningfully impact the implementation and enforcement of the Drug Supply Chain Security Act (“DSCSA”) as...more
The Food and Drug Administration ("FDA") recently issued its first warning letter to a domestic entity after conducting a remote regulatory assessment ("RRA"), indicating increased confidence and likely broader use of RRAs in...more
On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more
In June 2024, the U.S. Food and Drug Administration ("FDA") clarified, with respect to the Drug Supply Chain Security Act (“DSCSA”), that it will not extend the one-year stabilization period for the enhanced drug distribution...more
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came...more
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more
On March 20, 2024, the US Food & Drug Administration (FDA) issued a proposed rule titled Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the...more
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
Although we are only two and a half months in, 2024 has already seen its fair share of impactful 340B developments on both the litigation and legislative fronts....more
FDA’s January 3, 2024, Federal Register notice soliciting comments on the agency’s plan to implement best practices for guidance development got me thinking. What do the data show regarding FDA’s performance in moving...more
The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more
This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more
In anticipation of the US Food and Drug Administration (FDA) budget request for Fiscal Year (FY) 2025, this alert provides an overview of the agency’s most recent priorities as outlined in FDA’s FY 2024 budget, found here....more
Better Than Ezra’s early 1990s single, “This Time of Year,” came to mind when we saw the Food and Drug Administration’s Office of Prescription Drug Promotion issue its first Untitled Letter (also known as a Notice of...more