Teva Pharmaceutical Industries received an FDA warning letter over its API manufacturing plant in China — the company’s second in six months. Source: Drug Industry Daily
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Source: Drug Industry Daily
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…
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…
The FDA cited an Indoco Remedies API facility in Goa, India, for serious quality failures and inadequate handling of complaints. Source: Drug Industry Daily
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.…
The FDA cited Guardian Drug Company over quality and data storage issues. Source: Drug Industry Daily
The U.S. Court of Appeals for the Federal Circuit upheld a lower court decision that Sun Pharma did not infringe on Takeda’s patents when developing a generic version of Prevacid…
In yet another pressure point on generic drug prices, a class action suit filed in a Pennsylvania federal court claims Actavis, Teva, Sandoz, Fougera and Taro conspired to fix the…
The FDA cited a Mylan Pharmaceuticals facility for massive quality control problems and inadequate data integrity. Source: Drug Industry Daily