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Cynthia Schnedar, director of CDER’s Office of Compliance, stepped down from her role on March 18 to take an unspecified private sector job, according to an email from CDER Director Janet Woodcock. Tom Cosgrove, who until recently served as director of the OC’s Office of Manufacturing Quality, assumed her position on April 4. Read More
Two compounding operations are facing FDA allegations of producing adulterated drugs and doing so without prescriptions following agency inspections. Read More
Lunada Biomedical is barred from claiming that a dietary supplement can address perimenopausal and menopausal symptoms under a settlement agreement with the Federal Trade Commission. Read More
With clinical trial sponsors facing a slew of recruitment obstacles, one organization is recommending strategies to improve participation rates. Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Roche’s Perjeta, raising concerns about the lack of evidence backing the drug’s long-term benefits. Read More
As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Read More