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The FDA intends to listen carefully to recent recommendations made by its drug-safety advisers, particularly suggestions that the agency begin tapping emerging electronic databases to improve its oversight of marketed drugs, the FDA’s top drug-safety officer said.
The FDA’s new Drug Safety Oversight Board (DSB) will enforce strict conflict-of-interest rules to ensure its members make independent decisions, according to top agency officials who acknowledged that the duties of the board are still a work in progress.
Following on the heels of other recent guidances intended to help firms better monitor drug-safety issues, the FDA released a final guidance in April that describes a method for summarizing identified drug risks, particularly those found early in the postmarketing period.
Alcon Laboratories’ website for Cipro HC Otic eardrops fails to disclose risk information and overstates the efficacy of the product, states an FDA warning letter.
Exploratory clinical trial sponsors involving drugs and therapeutic biological products have not been taking full advantage of the flexibility offered in terms of the amount of data that needs to be submitted with early exploratory investigational new drug (IND) applications, the FDA said.
The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has cited Boehringer Ingelheim Pharmaceuticals for running a journal advertisement containing unsubstantiated superiority claims about its stroke drug Aggrenox.
The FDA has issued a warning letter to Canadian drugmaker Germiphene after an inspection of the company’s Brantford, Ontario, plant revealed significant deviations from current good manufacturing practices (cGMPs).
The number of adverse event reports submitted to the FDA’s Center for Drug Evaluation and Research (CDER) increased nearly 14 percent in 2004, according to a preliminary estimate from the agency.
The FDA has issued a public health warning about the potential cancer risks of two eczema drugs — Novartis Pharmaceutical’s Elidel and Fujisawa Healthcare’s Protopic.
A lack of leadership combined with increasing pressure to approve new drugs quickly and the Bush administration’s antiregulatory philosophy has left the FDA “timid and toothless,” according to an editorial in the March 17 issue of The New England Journal of Medicine (NEJM).