Quality Systems

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).

ISPE’s latest guide ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry focuses on how knowledge management allows for a more effective pharmaceutical quality system.

The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.

The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.

The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

The company is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL because of incorrect labeling.

The company is recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial because of visible particulates.

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

The EC’s approval of GSK’s Benlysta (belimumab) marks the first and only biologic approved for both systemic lupus erythematosus and lupus nephritis.

The European Commission has approved an additional indication for Roche’s Tecentriq (atezolizumab) as a first-line monotherapy treatment for metastatic non-small cell lung cancer.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Janssen has submitted a marketing authorization application to EMA seeking approval of its investigational BCMA-directed CAR-T cell therapy.

FDA is threatening enforcement action against a clinical trial sponsor that has ignored requirements to post study results on the ClinicalTrials.gov website.

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

Both the European Commission and FDA have granted approval to GlaxoSmithKline’s Jemperli (dostarlimab) for treating endometrial cancer.

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.

Applying a QbD approach helps address excipient variability and other quality features.