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The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American manufacturers. Read More
Generic drugmakers in the U.S. and EU are calling on regulators to create uniform approval pathways for biosimilars and generic medicines, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis so that patients can get them sooner. Read More
Drugmakers that are obtaining biotechnology-derived proteins in the EU should include effective evaluation and verification studies in their process validation documentation, the European Medicines Agency says. Read More
The European Medicines Agency is urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic profiles as the gold standard in proving efficacy similarity to their reference products. Read More
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted last month. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to the European Medicines Agency verifying that the information used to gain marketing authorization remains valid in practice. Read More
The European Medicines Agency is recommending that clinical trial sponsors evaluate local tolerance of medicinal products at contact sites on the body as part of a trial’s general toxicity studies. Read More
Drugmakers could be hit with huge medical bills for patients harmed during clinical trials, if proposed reforms to India’s drug laws are adopted. Read More