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September 02, 2015
Operator attention to detail and adherence to procedures are crucial for proper cleaning.
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
September 01, 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.
August 27, 2015
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
August 17, 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.
*This article is an opinion piece and does not necessarily represent the views of BioPharm International.
August 11, 2015
The agency issues guidance for companies considering registering with FDA as an outsourcing facility.
August 03, 2015
FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.
August 02, 2015
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.