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Independent third-party inspections could begin next month, and if the program is successful, the FDA will resume full-scale facility inspections, according to David Feigal, director of the Center for Devices and Radiological Health.
The FDA is attributing its adoption last year of a three-pronged strategy for increasing the numbers of approvals and faster review times during calendar 2003 and hopes to use the strategy to decrease review times further, the agency announced yesterday.
Several print and television ads for Aventis Pharmaceuticals’ leading allergy product have been pulled following the FDA’s assertion that the ads made misleading superiority claims over other remedies, the firm announced on Wednesday.
A Tufts University study has confirmed suggestions by the FDA that limited funds in the Center for Drug Evaluation and Research’s (CDER’s) budget might pose a serious threat to counterbioterrorism efforts, the review of complex new product applications and increased postmarket surveillance activities.
The FDA has granted generic firm Andrx conditional approval for its new mania and seizure treatment valproate delayed-release tablets, which is similar to brand firm Abbott Laboratories’ profitable drug Depakote.
The U.S. drug supply chain should adopt a “one step forward, one step back” model of documenting drug products until electronic track and trace technologies can be developed and adopted by the industry, Johnson & Johnson (J&J) told the FDA.
Transkaryotic Therapies (TKT) said it has abandoned efforts to get FDA approval for Replagal, a treatment for Fabry disease, a rare genetic fat-storage disorder that leads to fatal complications.
The FDA has sent Kos Pharmaceuticals a warning letter citing quality system deficiencies observed during an inspection of the drugmaker's main manufacturing facility, the company announced Monday.
With generic drugmakers expected to file a record number of applications this year, the FDA's Office of Generic Drugs (OGD) hopes not only to meet the increasing workload but to actually speed the approval process.
Facing increasing pressure from drug manufacturers to limit the flow of counterfeit drugs, the FDA may have to finally implement the repeatedly stayed final paper pedigree rule this April and burden small distributors with the task of proving the source of their goods.