Quality Systems

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.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

Paperless operations improve efficiency and increase assurance of product quality.

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.

FDA and industry support global framework and collaborations to secure the supply chain.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general council, both of Regulatory Compliance Associates, discuss the requirements for a successful corrective action and preventive action (CAPA) system.

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.

Create an efficient global labeling strategy that is compliant with both electronic and paper-based package-insert requirements.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.