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PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. Read More
Labeling on drugs and biologics approved under the FDA’s accelerated approval pathway should clearly state that the product was approved based on limited data so that healthcare providers are acutely aware of the product’s potential limitations, the agency says. Read More
The Arkansas Supreme Court reversed a $1.2 billion verdict against Johnson & Johnson concerning its marketing practices for the antipsychotic Risperdal, giving the pharma giant another crucial legal victory. Read More
European drugmakers can expect a more globalized European Medicines Agency, according to the regulator’s 2014 work program, which includes an increase in joint inspections with international counterparts, improving the agency’s support for companies in early-stage drug development and completing the rollout of the massive new pharmacovigilance requirements begun in 2012. Read More
The U.S. Food and Drug Administration and European Medicines Agency have launched a new information-sharing initiative aimed at speeding international responses to drug safety problems. Read More
The European Medicines Agency is advising drugmakers to create a separate program to assess the effectiveness of risk-minimization efforts for each marketed drug. Read More
The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. Read More
Australia’s Therapeutic Goods Administration (TGA) said Tuesday it is evaluating the potential safety risks of Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma occurring in patients using the drug. Read More
PhRMA is seeking substantial changes to the FDA’s proposed generic drug safety labeling rule, saying the agency should pre-approve all safety labeling changes for drugs with more than one manufacturer. Read More
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More