Insights on Drugs & Biologics

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”

ArentFox Schiff is pleased to announce that Abha Kundi has joined the firm as Counsel in the Food, Drug, Medical Device & Cosmetic practice in Washington, DC.

There are currently six states with active Prescription Drug Affordability Boards (PDABs) — Colorado, Maryland, Washington, Oregon, New Hampshire, and Minnesota.

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India.

With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on the use of artificial intelligence (AI) in the context of drugs, biologics, and medical devices.

Earlier this month, the US Food and Drug Administration (FDA) issued new draft guidance regarding their accelerated approval pathway for new drugs and biologics, an expedited program designed to help address unmet medical needs for serious or life-threatening conditions. As usual, the FDA is soliciting comments to the new guidance, due by February 4, 2025.

This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.

In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing Program, particularly with respect to contract pharmacies.

On July 16 the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) jointly issued warning letters to five companies for illegally selling “copycat” food products containing delta-8 tetrahydrocannabinol (THC).

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules.

A recent US Supreme Court decision, which grabbed headlines because it involved an abortion-related drug, with potential repercussions in litigation far-removed from health care due to the decision hinging on “standing,” i.e., when parties have been injured in a manner permitting them to sue.

Welcome to the April 2024 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month.

A major new research paper has concluded what many doctors had long believed was true – that patients can be switched between reference (or name brand) biologics and biosimilars with no issues involving the safety profiles or immunogenicity rates of the two drugs.

Partner Emily Leongini and Associate Shoshana Golden were quoted on US Food and Drug Administration’s (FDA) request for additional information from HRA Pharma’s NDA sponsor of a proposal for the country’s first over-the-counter (OTC) daily oral contraceptive.

“Metaverse” is no longer a mere buzzword. Many industries are discovering and developing applications for the Metaverse, and the pharma and biotech industry is no different.

The Food and Drug practice at ArentFox Schiff has received numerous inquiries from clients about long COVID, so we decided to ask our in-house scientist, Robert Edwards, Ph.D., Director of Regulatory Science, to prepare an Alert addressing many of the inquiries we have received.

In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the goal of safe importation of prescription drugs.”

We have seen biopharmaceutical companies around the world partnering to tackle COVID-19 in diagnostics, treatment development, vaccine development, and other relief efforts, including monetary and in-kind donations of lab equipment, instruments, and personal protective equipment (PPE).

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-CV-06593 (N.D. Cal. Oct. 16, 2020).

Food, Drug, Medical Device & Cosmetic Group Leader Deborah Shelton is serving as Curriculum Advisor for the Food and Drug Law Institute’s Introduction to Drug Law and Regulation virtual event on April 15-16.

On March 31, Health & Human Services Secretary Alex Azar announced the creation of a new FDA program, the Coronavirus Treatment Acceleration Program (“CTAP”), designed to speed up the development of life-saving treatments that have the potential to be both safe and effective.

In a letter dated March 28, FDA announced it was issuing an Emergency Use Authorization for oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19.

Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.