Partner David Rosen is quoted in a Bloomberg Law article, “Drug-Device Rules Could Give FDA Leg Up in Industry Fights,” about the FDA’s plan to revamp its rules on how to deal with overlapping drug, device and biologic products.
Rosen said it makes a big difference how a product is classified and which FDA office reviews it. “People would love products, for example, to be medical devices when they possibly can because it’s a lot less expensive and the time frame is generally a lot shorter,” he said.
He also said one proposed change – which would clarify that only product sponsors (such as drug companies or device makers) can submit a request for designation to suggest how a product should be classified and which office should be assigned to review it – is likely to be challenged because sponsors don’t always want to be identified early in the development process. “They want to keep things confidential so they engage us lawyers to write these requests without definitely identifying who they are,” he said.
Subscription required.
Rosen said it makes a big difference how a product is classified and which FDA office reviews it. “People would love products, for example, to be medical devices when they possibly can because it’s a lot less expensive and the time frame is generally a lot shorter,” he said.
He also said one proposed change – which would clarify that only product sponsors (such as drug companies or device makers) can submit a request for designation to suggest how a product should be classified and which office should be assigned to review it – is likely to be challenged because sponsors don’t always want to be identified early in the development process. “They want to keep things confidential so they engage us lawyers to write these requests without definitely identifying who they are,” he said.
Subscription required.
People
Related News
December 3, 2025
In the News
Vanessa Miller Assesses Automotive Tariff Impact on Trucking Industry
Foley & Lardner LLP partner Vanessa Miller discussed the ongoing disruption in trucking demand resulting from recent automotive tariffs in the TruckingDive article, “Tariffs swing volumes up and down for auto haulers.”
November 28, 2025
In the News
Cassandra Aubert Assesses Circuit Split on SEC Disgorgement Authority
Foley & Lardner LLP associate Cassandra Aubert commented on the growing scrutiny around the U.S. Security and Exchange Commission's disgorgement authority in the Bloomberg Law's article, “SEC Power to Recoup Illegal Profits at Risk as Justices Eye Case."
November 25, 2025
In the News
Gregory Husisian Analyzes SCOTUS Tariff Case
Foley & Lardner LLP partner Gregory Husisian appeared in a SupplyChainBrain video interview to discuss the U.S. Supreme Court case on the Trump administration’s imposition of tariffs under the International Emergency Economic Powers Act (IEEPA) and options the administration can consider should the court strike them down.