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In a new draft guideline, the World Health Organization (WHO) offered recommendations on complying with data integrity, GMP documentation and recordkeeping requirements. Read More
The European Medicines Agency’s biggest pharmacovigilance challenge in the next decade will be evaluating on-market efficacy, according to senior agency officials. Read More
Sens. Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) question whether authorized generics can “deliver real savings” to consumers, in a new report that finds Eli Lilly’s own generic of its blockbuster insulin product, Humalog, is not available in most pharmacies. Read More
In a court filing, California’s Attorney General is pushing back against a last-ditch effort by generic drugmakers to block California’s new pay-for-delay law. Read More
PhRMA is suing the state of Oregon in federal court to block enforcement of two drug price transparency laws — including one set to go into effect on January 1. Read More
Sponsors voluntarily submitting drug development tools (DDT), such as biomarkers and clinical outcomes assessments, to the FDA will have to undergo a new qualification process, according to a draft guidance the agency issued Friday. Read More