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The European Commission wants drugmakers to use a risk-management approach to qualify and validate manufacturing processes that covers the lifecycle of the product. Read More
Drugmakers can help to facilitate facility inspections — and improve their inspection experience — by engaging in constructive conversations with agency investigators, an FDA official says. Read More
To avoid getting cited for poor laboratory controls when FDA investigators come calling, manufacturers should study the mistakes made by their peers, one expert says. Read More
A federal judge has ordered the FDA to turn over all records concerning Otsuka’s Abilify sNDA to the U.S. district court in Maryland by Monday, saying the agency is attempting to delay litigation over exclusivity of the blockbuster antipsychotic. Read More
The Federal Trade Commission Wednesday approved Novartis’ divestiture of its targeted cancer drug business, clearing the way for a portfolio swap with GlaxoSmithKline valued at $21 billion. Read More
Novo Nordisk is moving forward two years after the FDA rejected two insulin therapies, with the agency’s agreement to review Class II resubmissions of its NDAs for Tresiba and Ryzodeg drugs based on an interim analysis of data from a cardiovascular outcomes study. Read More
Merck’s investigational hepatitis C grazoprevir/elbasvir combination pill has picked up two new breakthrough designations, just three months after the FDA threatened to rescind one it had already granted to the drugs. Read More