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In a deal set to strengthen two different clinical research platforms, Bluebird Bio has sold one of its rare pediatric disease priority review vouchers (PRV) to the immunology company Argenx for $102 million. Read More
In FDA’s ongoing efforts to clean up the accelerated approval (AA) program, the agency has withdrawn approval for an antibiotic cream that’s been on the market for 24 years without its required confirmatory trial to show that the product works. Read More
The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new report in JAMA Network. Read More
A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
The FDA is not extending its enforcement discretion policy for Investigational New Drug (IND) requirements governing the use of fecal microbiota for transplantation (FMT) obtained from stool banks for treatment of C. difficile infection that is not responding to standard therapy, the agency said in a final guidance released yesterday. Read More
Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies. Read More
Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its surrogate endpoints — and the pathway has stayed firmly in the limelight ever since, facing increasing scrutiny from seemingly all quarters. Read More