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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
December 19, 2017
The European Commission has closed its infringement procedure against Roche after the company completed remedial actions.
December 18, 2017
The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
The agency has proposed a risk-based enforcement approach to protecting patients against unproven homeopathic drugs.
The agency published guidance on the research and development of individualized therapies.
December 14, 2017
The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.
December 13, 2017
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.
December 12, 2017
The agency has posted a warning letter to companies promoting Coco Loko, a snortable chocolate powder, and Legal Lean, a drink, as substitutes for street drugs.