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Latest From Drug Safety
The World Health Organization estimates that one in 10 Medicines in the developing world are falsified. It says that the pharmaceutical industry needs to be more transparent about the problem.
The TGA says that its new search function to help generic drug sponsors identify new and updated product information will become more valuable over time.
The goal of monitoring Twitter and chat rooms is to proactively identify patterns of misuse and abuse before they fully manifest, Commissioner Gottlieb says.
Although study was meant to be critical of expedited pathways, it showed that drugs with at least one of the designations experience lower clinical development times.
US Supreme Court asks Solicitor General to weigh in on Merck petition requesting clarification of its Wyeth v. Levine ruling; Third Circuit says decision is 'cryptic and open-ended.'
Importance of randomized, controlled trials and need for a thoughtful, considered approach to development of rational combinations are highlighted by the increased mortality risk seen with pembrolizumab treatment in two halted multiple myeloma studies, FDA officials say.
The EMA’s drug safety committee has re-examined its recommendation in September to suspend modified-release paracetamol at the request of two companies that sell such products.
Former Commissioner Margaret Hamburg made advancing regulatory science a centerpiece of her tenure, but it sounds like the term ‘regulatory science’ has outlived its usefulness.
Stakeholder group's proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability.
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