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July 03, 2019
The guidance document provides recommendations for developing content for Instructions-for-Use documents for human prescription drugs, biological products, and drug-device or biologic-device combination products.
FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
July 02, 2019
CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.
AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).
Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.
Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?