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The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More
Four pharmaceutical companies that dramatically raised prices for decades-old, off-patent drugs all followed a series of steps designed to create and defend a monopoly on the product — allowing them to control the product’s prices with little, if any, market interference, according to a Senate committee investigation. Read More
The FDA plans to require risk evaluation and mitigation strategies for opioid analgesics — including immediate, extended-release and long-acting formulations — to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose and death. Read More
Spain’s Agency of Medicines and Medical Devices has ordered Madrid vaccine maker Angulema to suspend manufacturing and recall drug batches over GMP deficiencies. Read More
A group of Senate Democrats said they were willing to work with the incoming Trump administration to lower prescription drug prices and change the status quo. Read More
Six pharmaceutical companies are pushing for the dismissal of a False Claims Act suit by the City of Chicago over their promotion of opioids, arguing that the city has yet to provide factual evidence of any harm. Read More