Quality Systems

The agency has set up a workshop on how to demonstrate the benefits of orphan drugs over existing treatments.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

UPS joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

To enable efficient monitoring systems, life-science companies need to effectively apply run rules.

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

Virtual pilot programs that simulate scenarios can help the pharmaceutical industry address core issues in the implementation of serialization systems that comply with the US Drug Supply Chain Security Act.

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.

FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

The agency issues guidance for companies considering registering with FDA as an outsourcing facility.

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.