Quality Systems

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.

PRAC has recommended the marketing authorization of ulipristal acetate for the treatment of uterine fibroids be revoked.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

Risk-based decision-making is impacting all aspects of manufacturing quality from raw material supply to facility inspections.

Despite pharmacovigilance legislation being in place for nearly a decade, many companies are still struggling to fulfill obligations.

Processes, people, and tools are needed to comply with the pharmacopoeia and approved drug product registrations.

The 2020–2025 EMRN strategy will be regularly reviewed over the coming five years to accommodate science and technology advances.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

An assessment can identify the critical systems and the gaps in compliance based on intended use, says Siegfried Schmitt, vice president technical, Parexel.

The guidance recommends steps to detect and prevent nitrosamine impurities in pharmaceutical products.

The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.

The agency sent a warning letter to Acella Pharmaceuticals detailing CGMP violations and failures to oversee contract manufacturers.

The agency sent a warning letter after an inspection of the company’s Sangareddy District, India found inadequate cleaning procedures.

Hahn promises transparency in the review and approval of COVID-19 vaccines.

Under expanded FDA authorization, Gilead Sciences’ antiviral treatment for COVID-19 can be administered to all hospitalized patients.

FDA issued an emergency use authorization for COVID-19 convalescent plasma treatments following a report on NIH concerns about insufficient studies and data.

FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.