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Drugmakers need to rethink the role of their quality departments, particularly when engaging with stakeholders and the broader company, says Marla Phillips, director of health initiatives at Xavier University, who previously served as head of quality at Merck’s North Carolina facility. Read More
For the second time, a federal court dismissed a nonprofit’s lawsuit seeking to compel the FDA to amend its informed consent rules for clinical trials. Read More
In July, the FDA issued a decision letter relating to Suboxone generics, ruling that ANDA applicants can qualify for 180-day exclusivity whether or not they provide a certification under Paragraph IV. Read More
The judge said the plaintiffs “have not sufficiently alleged that Teligent had an opportunity to conspire with the other econazole defendants.” Read More
The U.S. Court of Appeals for the Federal Circuit upheld a 2017 ruling by the Patent Trials and Appeals Board rejecting Forward Pharma’s challenge to Biogen’s Tecfidera patent. Read More
The agency pointed out in its denial letter that the 180-day exclusivity period did not begin until Aug. 29, when the company actually notified the agency that it had begun commercial marketing. Read More
“Research suggests that using these formats to express probabilities when communicating health information can improve consumers’ comprehension and ability to recall the information” and improve their processing and evaluation, the agency said. Read More