Quality Systems

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.

Open communication and transparency coupled with technical expertise foster strong long-term manufacturing partnerships.

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing.

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The company is recalling one lot of Cisatracurium Besylate Injection, USP 10mg per 5mL because of mislabeling.

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).