On January 27, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Special Advisory Bulletin addressing direct-to-consumer (“DTC”) prescription drug programs. These DTC programs allow cash-paying patients, including those enrolled in Federal health care programs such as Medicare …
On January 12th, FDA approved Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. Menkes disease is a rare, congenital X-linked genetic disorder characterized by impaired copper absorption, leading to severe copper deficiency, progressive neurologic deterioration, and death in early …
FDA is moving with notable speed. Less than a month after announcing its inaugural class of Commissioner’s National Priority Voucher (CNPV) winners (see our previous post), the agency has already named its second cohort. The CNPV program, designed to accelerate the review of products that advance …
On September 30, 2025, FDA held a public meeting titled “Onshoring Manufacturing of Drugs & Biological Products.” Driven by Executive Order 14293, “Regulatory Relief To Promote Domestic Production of Critical Medicines,” the meeting focused on reducing U.S. dependence on foreign pharmaceutical sources and promoting investment …
No company wants to be on the receiving end of a Warning Letter, which is FDA’s primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements. Typically, a company who receives a Warning Letter must …
As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form …
