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The FDA has shut down four websites it claims sold bogus transdermal contraceptive patches containing no active ingredients, as part of its ongoing enforcement efforts against drug counterfeiters, the agency said Thursday.
The FDA has issued a warning letter to Xttrium Laboratories for failing to correct problems with its postmarketing adverse drug experience (PADE) reporting system for chlorhexidine gluconate products.
The FDA is urging the makers of hormone therapy (HT) products to update their labeling to include data from a clinical study that found women over 65 had an increased risk of dementia when taking oral conjugated estrogens plus medroxyprogesterone acetate.
Switching to a new file format required by the FDA to submit drug-label changes will almost certainly cause some short-term pain for the industry, but that should be offset by long-term gains in flexibility and uniformity, some industry experts say.
Dr. Reddy’s new drug application (NDA) for a generic version of Pfizer’s hypertension and angina drug Norvasc will undergo additional scrutiny from the FDA because of questions regarding the source of the clinical trial data submitted by Dr. Reddy’s.
A consumer activist group is urging HHS Secretary Tommy Thompson to use a little-known federal law on the commercialization of government funded inventions to grant generic drugmakers patent licenses to make versions of Pfizer’s glaucoma drug Xalatan (latanoprost) and Abbott’s AIDS treatment Norvir (ritonavir).
The FDA wants to tap into industry user fees, rather than congressionally approved funding, to pay for most of its new full-time employees, according to the agency’s proposed budget for fiscal 2005.
Some in the generic drug industry want the FDA’s Office of Generic Drugs (OGD) to put a hold on new rules, like requiring additional bioequivalency (BE) studies, if it becomes clear the agency isn’t able to handle an increasing workload with a Bush administration-proposed fiscal 2005 budget that keeps funding levels flat.
Although the FDA’s Psychopharmacologic Advisory Committee recently took a stand in favor of stronger warnings regarding the possible increased suicide risk in children using antidepressants, a health advocacy group wants the agency to remove three committee members who have done research, consulting and other work for manufacturers of those drugs.
The FDA has banned dietary supplements containing ephedra because of safety concerns — a move that marks the first time the agency has exercised that authority under the 1994 Dietary Supplement Health and Education Act (DSHEA).