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Sponsors of biosimilars need to demonstrate how their products compare with reference drugs, including pharmacokinetic and pharmacodynamic data to show compatibility in clinical trials, according to U.S. Food and Drug Administration draft guidance on non-brand versions of the complex therapies. Read More
The U.S. Food and Drug Administration has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
British drugmaker GlaxoSmithKline is facing another bribery probe, this time from a UK watchdog that plans to investigate the company’s global business practices. Read More
U.S. and European regulators have made strides toward mutual recognition of quality inspections, so that companies inspected by one regulator won’t face a second inspection by the other, but setbacks remain, a top EU regulatory official told IPRM. Read More
The U.S. Food and Drug Administration is trying to encourage mobile app and web developers to give wide distribution to drug adverse event information by providing the data in an easy-to-use electronic format. Read More
Europe’s major pharma association is criticizing a decision by Italian regulators that would allow the government to pay for an off-label eye treatment, saying the move is motivated by cost savings and could undermine the EU’s regulatory authority. Read More
Manufacturers looking to speed up drug approvals in the EU and ensure that their products are covered by payers should initiate parallel conversations with the European Medicines Agency and health technology assessment bodies early in the development process, the EMA says. Read More
Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More