Regulatory Oversight

Siegfried Schmitt, vice president, Technical at Parexel, offers insight into FDA’s guidance on performing operations during COVID-19.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

FDA published guidance for submitting standardized study data in electronic format.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.

For planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.

Consistent product quality requires a clear understanding of the essence of CGMPs. Experts fear that the message is not always getting through to compounders.

FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.

Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization.

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

The case for migrating from a paper-based quality management system to a digital platform is presented.

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.

Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.

The amount of detail included in SOPs may help a company stay compliant, says Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, LLC.

The guidance discusses acceptable clinical endpoints for demonstrating effectiveness of drugs developed to treat opioid use disorder.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Symbiosis has successfully completed a scheduled inspection by MHRA.

Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.