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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
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
The European Medicines Agency has rejected calls from industry to use biosimilar reference products from outside the EU unless they are justified using pharmacokinetic tests. Read More