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Latest From Drug Safety
US FDA commissioner says he would be happy to work with Congress on a legislative solution on the issue, but emphasized his priority is for the agency to develop a system itself to discourage REMS abuse.
State courts cannot exercise specific jurisdiction over personal injury claims brought by out-of-state residents, high court says in favorable decision for Plavix marketer Bristol-Myers Squibb. Ruling likely to result in smaller mass tort lawsuits, but more of them across the country.
Patients For Affordable Drugs Founder David Mitchell alleges Celgene's unlawful delay tactics like REMS obstruction kept generic versions of Thalomid and Revlimid off the market, forcing plaintiffs to pay higher costs.
FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.
Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.
Association for Accessible Medicines report highlights continuing upward trend of cost savings from generic drugs; trade group argues legislative proposals addressing restricted distribution misuse are key to accelerating savings.
Earlier withdrawals of Purdue’s Palladone and original OxyContin create precedent for request that Endo’s Opana ER come off market due to risk of abuse; former chief counsel sees agency's move as ‘tip of the iceberg’ on opioid safety actions.
Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.
Perrigo is recalling is Option 2 (levonorgestrel 1.5 mg) emergency contraceptive in US and Canada because the tablet is missing from some of 181,776 one-count packages.
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