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The FDA intends to publish a proposed rule that would replace current requirements for reports submitted on IND applications, according to an HHS inventory of agency rulemaking for 2017. Read More
Teva will pay $519 million — the largest fine levied against a drugmaker for violating a foreign corruption law — to resolve international bribery charges involving business operations in the Ukraine, Russia and Mexico. Read More
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