Regulatory Oversight and Compliance

An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

Workforce training is crucial for biopharmaceutical manufacturing.

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

Continued process verification for a cleaning validation program begins once the validation study is complete.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.

Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?

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.

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.

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

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.

PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.