Device makers, like pharmaceutical manufacturers, have long recognized that their success depends upon making their products known to physicians who will prescribe or recommend the use of their particular product.
In addition to their ability to influence current product use, physicians also are in the best position to conduct or oversee research that may expand future market share, including identifying additional clinical uses or adaptations for a product — some of which may not yet be approved by the U.S. Food and Drug Administration (FDA).
Read the complete article by clicking on the link below.
Reprinted with permission from Portfolio Media, Inc. This appeared in both Health Law360 and Competition Law360.
Author(s)
Related Insights
25 April 2025
Manufacturing Industry Advisor
Leaked Budget Proposal Suggests Major Restructuring of Federal Health and Safety Agencies, Including the Consumer Product Safety Commission
A recently leaked and apparently genuine Office of Management and Budget (OMB) Budget “Passback” memorandum—the OMB’s official feedback mechanism for budget submissions from federal agencies—signals major changes to the Department of Health and Human Services’ (HHS) proposed discretionary budget for Fiscal Year 2026.
24 April 2025
Foley Viewpoints
Prop 65: Changes to Short-Form Warnings Will Cause Long-Term Impacts
The California Office of Environmental Health Hazard Assessment recently amended its regulations concerning requirements for consumer product warnings to qualify for “safe harbor” protection from enforcement actions brought under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65.
24 April 2025
Tariff & International Trade Resource
What Every Multinational Company Should Know About … Customs Enforcement and False Claims Act Risks (Part II)
As detailed in Part I of our three-part series on Minimizing Customs Enforcement and False Claims Act Risks, the combination of the new high-tariff environment, the heightened ability of Customs (and the general public) to data mine, and the Department of Justice’s stated focus on using the False Claims Act substantially increases import-related risks.