Quality Systems

January is the kind of month that can make your head spin.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.

Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.

Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary.

EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Different methods to calculate limits for impurities will give different answers. The prediction interval method may be ideal.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.