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Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More
The European Medicines Agency will publish a guideline next year specifying how drugmakers will have to code and share medication errors with regulators. Read More
The Justice Department’s crackdown on drugmakers that violate the False Claims Act continues, with Astellas’ U.S. division paying $7.3 million to settle claims it improperly marketed Mycamine. Read More
The European Medicines Agency is urging healthcare providers to inspect vials of the cancer drug Herceptin for signs of tampering following reports that some vials of the drug were stolen in Italy, tampered with and reintroduced into the supply chain. Read More
Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that a bottle of the drug contained 50 mg metoprolol tartrate tablets instead. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
A federal judge Tuesday overturned Massachusetts’ ban of Zogenix’s controversial painkiller Zohydro ER, saying the state overstepped its authority. Read More
Drugmakers want the FDA to soften language in its first guidance on social media marketing that would make companies responsible for third-party content. Read More
Sponsors that use surrogate endpoints, such as biomarkers, in confirmatory cancer trials may need to provide postmarketing data to verify that the information used to gain marketing authorization in the EU remains valid in practice. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More