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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
Two FDA advisory committees grappled with the proposed addition of information from a pediatric study to labels for Purdue Pharma’s opioid patch Butrans (buprenorphine), without coming to a clear consensus. Read More
The U.S. government sided with Sandoz on the residual claims from the biosimilar manufacturer’s Supreme Court case with Amgen — arguing the federal law outlining the biosimilar approval process should preempt state laws on the topic. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More
Missouri’s Supreme Court upheld a $38 million verdict against Abbott Laboratories over claims its epilepsy drug Depakote caused birth defects. Read More
In the 1980s, heart medications accounted for 27 percent of all new drug approvals in the U.S. — a share that dropped by more than half in 2010-2016. Read More