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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
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
Recent action from a state legislature, as well as objections from industry groups, suggest the FDA should narrow its guidance for off-label claims, according to two prominent labeling attorneys. Read More
The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality. Read More