Yet another week with a preponderance of warning letters issued by the Center for Tobacco Products. We cover one warning letter issued to an OTC manufacturer in China.
GMP expert Jerry Chapman covers the presentation by FDA Office of Combination Products (OCP) Associate Director for Policy John Barlow Weiner in which he reviews PMSR guidance and implementation, the RFD process, and new guidance in progress.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.
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GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER’s Office of Compliance Annual Report for CY2018.
GMP expert Barbara W. Unger reviews the Office of Generic Drugs’ 2018 Annual Report.