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The FDA for the first time has consolidated all elements that generic manufacturers must include in their ANDAs in an effort to increase the success rate of new submissions. Read More
A European pharmaceutical trade group has blasted a decision by Italian regulators that would allow the government to pay for an off-label eye treatment, saying the decision was motivated by cost savings and could undermine EU’s regulatory authority. Read More
Faulty lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounder to receive a warning from the FDA. Read More
The European Medicines Agency is streamlining the declarations that Qualified Persons must file to assure the agency that makers of active substances are compliant with good manufacturing practices. Read More
The FDA chided Citius Pharmaceuticals for a webpage promoting its product Suprenza that omits risk information and makes overblown claims about the weight loss drug. Read More
The FDA should issue guidance on orphan drug development that provides a detailed set of deadlines and clarity on what exactly will be discussed at various meetings throughout the approval process, according to an industry trade group. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency said. Read More
For the third year in a row, pharmaceutical companies are filing more proposals with the European Medicines Agency’s pediatric committee seeking approval for the development of drugs for children. Read More