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The U.S. Department of Justice (DOJ) announced that three members of a Miami-based research center have been charged for allegedly running a years-long scheme to falsify clinical trial data for profit. Read More
In the wake of the reauthorization of the Generic Drug User Fee Amendments (GDUFA), the FDA has updated its guidance for prior approval supplements (PAS) and amendments for abbreviated new drug applications (ANDA) under GDUFA III. Read More
The Department of Health and Human Services (HHS) will have to come up with a plan to force down the cost of prescription drugs under an executive order signed by President Biden on Friday. Read More
Less that a third of regulatory actions spurred by safety signals in the FDA Adverse Event Reporting System (FAERS) weresupported by published studies, with most actions relying instead on case reports and none corroborated by FDA’s Sentinel Initiative, researchers at Yale University reported in the journal BMJ. Read More
Companies submitting or holding drug applications who plan to implement a chemistry, manufacturing, and controls (CMC) postapproval change may gain faster agency reviews using a comparability protocol (CP), according to a final guidance the FDA released on Thursday. Read More
After years of legal wrangling, the FDA is still grappling with the issue of how exactly to define “exclusivity” in its orphan drug program, according to one senior agency official who says legislative action may be needed to end the debate. Read More