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The FDA should require a Risk Evaluation and Mitigation Strategy to ensure patient use mimics clinical trial conditions, a CDC official said. Read More
Having naloxone widely available as an approved OTC product, is “an important public health advance and a need that we’ve been working on at the FDA,” Gottlieb said. Read More
Walgreens agreed to pay nearly $270 million to settle allegations the pharmacy giant violated the False Claims Act and overbilled Medicaid for prescription drugs. Read More
The Patent Trial and Appeal Board ruled last year that Native American tribes cannot use sovereign immunity as a defense against inter partes reviews. Read More
Sponsors should consider whether they need to conduct nonclinical safety experiments on drugs before moving on to pediatric trials, according to an ICH draft guideline the FDA released for comment on Tuesday. Read More
UnitedHealthcare accused dozens of generic drugmakers of a price-fixing conspiracy in a lawsuit that echoes previous complaints by Humana and a coalition of state attorneys general. Read More
The FDA released final guidance for sponsors on the indications and usage labeling section of drugs on the agency’s accelerated approval pathway. Read More
“With time running out we hope Parliament will come together and quickly find a solution to the stalemate,” said ABPI Chief Executive Mike Thompson. Read More