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A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
European regulators are looking to industry for suggestions on the best ways to get generic versions of topical drugs approved without having to conduct time-consuming and expensive clinical trials to prove bioequivalence. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
The European Commission has updated its GMP guideline on process validation to reflect the EU’s current risk-based approach to managing quality systems over the entire lifecycle of a drug. 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
Tennessee has joined a growing list of 11 states to pass legislation enabling pharmacists to substitute a biosimilar for a branded biological product, in a move applauded by industry. Read More
Dublin, Ireland-based Amarin Pharmaceuticals is asking a New York federal court to declare its off-label promotion of a cholesterol-lowering drug constitutionally protected free speech, after several FDA rejections of its desire to promote the drug for a wider patient population. Read More