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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
GlaxoSmithKline is appealing a $54 million fine from the UK’s Competitions and Market Authority over pay-for-delay allegations, contending the company’s conduct was “objectively justified.” Read More
Drugmakers are expected to collect individual cases of suspected adverse reactions linked to off-label use but not individual reports when there has been no associated adverse event, the EMA said in April. Read More
UK regulators have fined Pfizer $14,000 for failing to explain a questionable claim meant to justify price increases on the generic seizure medication Epanutin. Read More
The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies. Read More