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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
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
Teva is pointing to the Supreme Court’s recent ruling in a soft drink labeling case to claim immunity from GlaxoSmithKline’s lawsuit alleging the Israeli firm falsely advertised its generic antidepressant budeprion XL as bioequivalent to GSK’s Wellbutrin XL. Read More
Manufacturers of oral viscous lidocaine 2 percent solution must add a boxed warning to their product’s labeling that spells out the serious risks of using the painkiller to treat teething pain in children and infants. Read More