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The dramatic increase in the number of Class I recalls over the past year illustrates the need for companies to have a sound policy for
responding to potential problems with their products, an industry expert says. Read More
Perrigo is recalling 11 million bottles of 500-mg acetaminophen caplets after its metal detectors revealed small metal fragments in some of the product, which it manufactured and distributed under various store brands. Read More
President Bush's nomination of Andrew von Eschenbach to be the next FDA commissioner is at a stalemate as the agency and Sen. Chuck Grassley (R-Iowa) battle over access to an ongoing clinical trial investigation, an FDA source says. Read More
The FDA granted pediatric exclusivity for insomnia drugs Ambien and Ambien CR, giving sanofi-aventis six more months of patent protection, the company announced. Read More
Andrew von Eschenbach’s nomination to be the next FDA commissioner remains stalled as the agency’s efforts to reach a compromise with a prominent lawmaker over access to an ongoing clinical trial investigation have failed. Read More
The FDA is calling on the pharmaceutical industry to help its regulatory project managers gain a greater understanding of the drug manufacturing process as part of its ongoing effort to bridge the information gap between industry and the agency. Read More
The FDA’s Blood Products Advisory Committee will hold a public hearing next month to consider a request by the Naval Medical Research Center to conduct a clinical trial of Biopure’s blood substitute, Hemopure. Read More
In the latest step in the battle between drug wholesalers and the federal government over the FDA’s drug tracking rule, the agency must prove that it will suffer harm from a proposed stay of the rule, an industry source says. Read More
An FDA advisory panel is recommending that the anti-inflammatory drug Celebrex be approved for use in treating juvenile rheumatoid arthritis (JRA) — despite a virtual split among its members as to whether the drug would be safe in treating the disease. Read More