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A federal court invalidated five Mallinckrodt Pharmaceuticals patents on its Inomax respiratory treatment system in response to the company’s own lawsuit against Praxair. Read More
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
The FDA will move to close a loophole in the program to foster study of treatments for rare pediatric illnesses, agency commissioner Scott Gottlieb said in a blog post. Read More
Galena Biopharma agreed to pay more than $7.5 million to settle a whistleblower suit alleging the drugmaker violated the False Claims Act by paying doctors to prescribe its fentanyl-based drug Abstral. Read More
Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Read More