Quality/GMPs

The document includes recommendations for the reporting and implementation of changes to container closure system components.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, discusses the differences in how E&L study design should be approached based on whether the study is following ISO or USP standards.

Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

The EC is calling for interested parties for their safety and orphan drug committees.

According to USP, the products will advance quality and reduce risk in the development and manufacture of biologics and vaccines.

Re-evaluating the basics of mAb production may be beneficial for the biopharma industry as a whole.

USP offers strategies to minimize residual impurities in downstream processing.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

The commission’s membership will help facilitate reach and impact for standards harmonization.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Glycosylation analysis can provide a deep and nuanced understanding of immune cell phenotype and function.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

The agency will be reorganizing field force and compliance functions.

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Leaders at CDER and CBER give update on organizational changes at FDA.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.