Quality Systems

The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.

Auditing distribution suppliers provides understanding and documentation of the services performed, says Siegfried Schmitt, vice president, Technical at Parexel.

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health.

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

Labeling, printing, and on-dose tagging technologies provide a multi-layered approach to anticounterfeiting for pharmaceuticals.

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients.

The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

The selection of a new FDA commissioner has become a contentious issue in Washington, as the White House delays a decision and interest groups line up behind competing candidates.

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.

Anticounterfeiting technology protects the supply chain from manufacturer to patient.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

FDA puts applications on hold as the agency limits alternative oversight methods.

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.