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The FDA warned consumers on Aug. 30 not to buy prescription drugs from certain Canadian websites that are reportedly selling counterfeit drugs, and not to use such drugs if they have purchased them.
The FDA is balancing a number of factors in trying to assure that public health is protected and sufficient federal oversight is taking place, while addressing a funding situation that is unlikely to improve, current and former high-ranking agency officials say.
The federal government and industry must overhaul the way medications are named, labeled and packaged in order to curb an ever-growing number of medical errors involving the administration and prescription of drugs, a recent federal study concluded.
A recent state supreme court decision to review the validity of a class action claim concerning Merck’s drug Vioxx could undercut the national case against the company, an industry attorney says.
The FDA, under attack from Congress for its handling of the antibiotic Ketek, is now mandating new warnings for the drug, but may not have silenced its critics.
The FDA is attempting to improve regulatory compliance and reduce risk by reorganizing the Office of Regulatory Affairs (ORA), an agency memorandum says.
The FDA believes that improved use of epidemiological data and assessment of risk management plans (RMPs) are two priorities in its ongoing Prescription Drug User Fee Act (PDUFA) negotiations, a high-ranking agency official said.
The FDA’s own enforcement reports show it to be an agency under increasing pressure to do more with less — the number of warning letters is dropping even as recalls skyrocket, sources say.
The first year of the FDA’s Drug Safety Oversight Board (DSB) shows that the panel can help improve and accelerate drug reviews by providing a forum where senior officials can consult on drug safety issues, according to an agency official.