Quality Systems

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

pharmasol has completed the strategic merger with PharmaLex.

The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

Training is crucial for supporting GMP operations in commercial-scale bioprocessing.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.

Toxicology studies are an important and required aspect of drug development that are performed to ensure that drugs are deemed safe prior to patient administration and use in clinical trials.

Ensuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.

CDMOs offer expertise and customization options for sponsors of orphan drugs.

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

NICE has updated its Technology Appraisal Guidance TA599 for AstraZeneca’s Lokelma.

Merger with Phlexglobal expands provider’s technological capabilities.

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval process.

The company is voluntarily recalling one batch of Semglee prefilled pens because of a potential missing label.