We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The agency suggested using data from alternative sources, such as trials that use the drug for other indications or studies of similar treatments. Read More
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