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March 15, 2020
This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.
This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.
In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
March 13, 2020
The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).
EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.
March 06, 2020
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.
March 05, 2020
FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.