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January 22, 2016
FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.
January 21, 2016
FDA issued a warning letter to Chan Yat Hing Medicine Factory for CGMP violations.
January 05, 2016
FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.
January 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL, discusses how to streamline the document management process during market expansion.
The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.
December 17, 2015
The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.
December 10, 2015
FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.
December 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
December 04, 2015
The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.
December 02, 2015
Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss how to write standard operating procedures that hold up to audits.