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June 01, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses training personnel on data integrity.
May 31, 2016
The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.
May 19, 2016
The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.
May 17, 2016
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
May 15, 2016
Erring on the side of safety is a well-established way of ensuring patient safety, but it may now be getting out of hand, as product recalls and withdrawls deprive patients of necessary treatments without the surety that recalled product would have caused any harm to the patient.
This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.
May 02, 2016
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
April 25, 2016
The agency publishes draft guidance on assay development and validation for immunogenicity testing.
April 19, 2016
The guidance discusses the implementation of CMC postapproval changes through a comparability protocol.
April 18, 2016
The agency published guidance on data integrity as it is relates to CGMP compliance.