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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
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
The UK’s National Institute for Health and Care Excellence (NICE) said it will cover Johnson & Johnson subsidiary Janssen-Cilag’s diabetes drug Invokana (canagliflozin) as a treatment for people with type 2 diabetes. Read More
European regulators are advising drugmakers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements, and serious violations will face EU Phramacovigilance Risk Assessment Committee (PRAC) review. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
Akorn Enterprises, or its new subsidiary Hi-Tech Pharmacal, was required to sell the marketing rights for five generic drugs to Watson Laboratories to settle federal charges that Akorn’s acquisition of Hi-Tech was anticompetitive, the FTC said. Read More
Australian pharmaceutical regulators have finalized an extensive list of drug products and risk statements that manufacturers of nonprescription drugs should use when changing their labels to meet a requirement that goes into effect at the end of next year. Read More