Quality Systems

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

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

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

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 designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.

Companies can benefit from developing a single programmatic approach to a GxP training matrix.

The agency is warning patients and healthcare providers about pre-filled pens falsely labeled as Ozempic.

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

This approval builds on a previous approval of the combination therapy for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

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

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

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

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).

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

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.

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

Data integrity is crucial in unlocking novel data-based insights.

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

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

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.

VistaPharm is recalling Sucralfate Oral Suspension, 1g/10mL because of Bacillus cereus contamination.