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The FDA is proposing a surveillance plan for Merck’s Gardasil 9 to screen for four potential adverse risks associated with human papillomavirus vaccines. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
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
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
The U.S. Senate and House passed spending bills to fight the Zika virus within 24 hours of each other. The distinct measures both include HHS funding for vaccines, therapies and diagnostic tests. Read More
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. Read More
The Secretary’s Advisory Committee on Human Research Protections is recommending that the FDA revise its informed consent waivers for cluster randomized trials to mirror HHS rules. Read More
The Senate Appropriations Committee unanimously approved a fiscal 2017 funding bill Thursday that would provide the FDA with $4.78 billion in total funding, around $100 million above the current funding level. Read More
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More