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High-ranking FDA officials visiting India have laid out a new approach to facility inspections for Indian manufacturers that would reward firms if their quality management system exceeds minimum compliance requirements. Read More
The FDA warned Cadila Pharmaceuticals for cGMP violations that include quality controls, complaint handling and data integrity at its Gujarat, India, active pharmaceutical ingredients manufacturing plant. Read More
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