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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.
August 24, 2021
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
August 20, 2021
MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.
ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.
EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.
The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.
FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.
UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.