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Concerns that limited funds in the Center for Drug Evaluation and Research’s (CDER’s) budget could pose problems with that center’s expanded mission in counterbioterrorism, new product applications, and postmarket surveillance were independently confirmed by a recently released Tufts University study.
Generic firm Andrx announced it has received conditional approval from the FDA for its new mania and seizure treatment valproate delayed-release tablets, which is similar to brand firm Abbott Laboratories’ profitable drug Depakote.
Concerns about raw material used to make a generic version of Bristol-Myers Squibb’s diabetes drug Glucophage XR have prompted the FDA to withdraw the tentative approval it gave to Barr Pharmaceuticals, the firm said Jan. 9.
Not sitting idly by while one of its most successful painkillers prepares for generic launch, Purdue Pharma has petitioned the FDA to withhold final approval for a generic version of OxyContin until generic firms implement appropriate risk management plans (RMPs) and has filed its notice to appeal a recent court decision.
Patent reforms in the recently enacted Medicare drug benefit should help the FDA make decisions that will withstand legal challenges as brand firms fight vigorously to protect their products, and generics compete for billions of dollars worth of drugs going off patent.
With cracking down on the trafficking of counterfeit drugs a major priority, FDA will be hard pressed 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.
Print and television ads for Aventis Pharmaceuticals’ leading allergy product made unsubstantiated superiority claims to other prescription remedies on the market, according to an untitled letter released by the FDA, which caused the firm to pull the ads in response, Aventis announced Jan. 14.
Drug distributors should be required to document where a drug product has come from and where it is going to at least one step in the distrubution chain until electronic track and trace technologies can be developed and adopted by the industry, Johnson & Johnson (J&J) told the FDA recently.
Devicemakers need to consider the primary audience for the sections of the premarket approval (PMA) application that receive the most FDA scrutiny to facilitate a more focused, orderly and timely review by the agency.