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The FDA has unveiled enhanced warnings for opioid pain medications that will affect 141 generic and 87 innovative immediate-release opioid products, which account for roughly 90% of all prescription opioids. Read More
The FDA and the National Institutes of Health are seeking comments on a new draft clinical trial protocol template for NIH-funded investigators. Read More
The European Medicines Agency has begun a public consultation on planned revisions to Module V of the good pharmacovigilance practices on risk management systems, which clarifies what risk management plans to focus on over a product’s lifecycle. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues. This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More