PHARMACY

FDA to establish eight permanent positions in China

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Friday announced that the agency has gotten the green light from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange and cooperation, especially on product quality and enforcement matters,” stated Murray Lumpkin, deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs and medical devices in the global market.”

In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou. 

According to the agency, the permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality before they actually reach U.S. shores.

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FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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