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.
Arkansas Attorney General Leslie Rutledge petitioned the Supreme Court to uphold a state law that requires PBMs to reimburse pharmacies after they dispense drugs to patients at wholesale inventory costs. Read More
The FDA released a draft International Council for Harmonisation guideline explaining how sponsors can waive in vivo bioequivalence clinical trials using the Biopharmaceutics Classification System (BCS). Read More
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