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The FDA has rejected Advanced Accelerator Applications’ candidate for the treatment neuroendocrine tumors in adults, requesting that the company submit new analyses and correct manufacturing deficiencies. Read More
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