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The importers of a Chinese acupuncture device have drawn the attention of the FDA for failing to have the product cleared by the agency before marketing it in the U.S.
The FDA’s Orthopedics and Rehabilitation advisory panel voted unanimously June 3 to conditionally approve the Charite artificial disc, manufactured by Johnson & Johnson subsidiary DePuy Spine.
Boston Scientific last week acquired privately held neuromodulation firm Advanced Bionics for $740 million cash, plus further payments tied to future performance milestones.
The FDA on June 3 published its long-awaited guidance on its Inspection by Accredited Persons (AP) Program -- a step that should clarify for devicemakers the criteria needed to utilize third-party inspectors.
The FDA last week announced the availability of the most recent cumulative list of orphan drug and biological designations as of Dec. 31, 2003. The list includes the name of the drug or biologic, the condition/disease for which the drug or biologic is indicated and contact information for product sponsors.
Generic drugmaker Sandoz intends to become the first firm to launch a generic biologic by putting its human growth hormone product Omnitrop on the market in Europe next year.
Peter Pitts, the FDA’s associate commissioner for external relations, will be leaving his position, effective June 18, to become senior vice president for health affairs in the New York City office of public relations firm Manning, Selvage and Lee.
Legislation sponsored by Sen. Judd Gregg (R-N.H.) to legalize drug imports from Canada and the European Union includes provisions that would establish federal licensing requirements and penalties for internet pharmacies.