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Shire ViroPharma has asked a Delaware federal court to dismiss an FTC complaint accusing the drug company of abusing the citizen petition process. Read More
Teva Pharmaceutical Industries received an FDA warning letter over its API manufacturing plant in China — the company’s second in six months. Read More
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past five years Read More
The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines. Read More
The Trump administration’s federal hiring freeze officially ended yesterday — but OMB Director Mick Mulvaney has warned the FDA and other federal agencies to prepare for deeper, long-term staff cuts. Read More