NDAC and ORUDAC members acknowledged the FDA’s concerns about some data provided by Opill sponsor HRA Pharma to support its OTC switch application. However, a greater share noted the “historic nature” of the proposal and the broad support expressed in the meeting’s public comment portion.
Members of a US Food and Drug Administration advisory panel, to a person, concluded that the potential benefits of OTC sales of a daily oral contraceptive outweigh the risks.
Several agreed with FDA concerns about some data the sponsor of the application for the OTC switch provided, but a larger number noted the historic nature of HRA Pharma’s proposal and of their two-day
“The situation has evolved considerably” since Kenvue gave its initial full-year outlook in February, “and remains quite fluid,” says president and CEO Thibaut Mongon as firm reports Q1 net sales decreasing 3.9% to $3.7bn
Looming imposition of tariffs by Trump on imports from most every country had an influence on consumers during the January-March period, particularly on online shopping. Increasing product prices on the table, “but our efforts are going to start with cost savings,” says CFO Christine Sacco.
Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.
