Quality Systems

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

This case study is based on the experience of one of the authors but is applicable to all companies across the broader industry, illustrating the potentially surprising point that some compliance difficulties may be of the company’s own making.

This article details the more operational aspects of monograph submissions, answering the question of how to participate.

This article explores a proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.

This article presents a case study at the intersection of monograph development and compliance.

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.

The agency is postponing the inspection of most foreign facilities through April 2020.

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.

The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.

Emergency action to protect patients and the drug supply may have long-term implications.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

A study finds a potential risk of persistent visual side-effects in male patients taking the highest recommended dose of sildenafil.

While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

US and European regulatory officials continue to anticipate supply shortages in multiple areas.

An evaluation by USP indicates bovine heparin is a potential alternative to porcine heparin.

FDA’s Center for Biologics Evaluation and Research is planning on publishing nine specific guidance documents on gene therapies in 2020.