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January 02, 2020
Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.
Focusing on symptoms instead of root causes locks teams into a corrective, rather than preventive, mindset.
Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.
Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.
December 18, 2019
Glenmark Pharmaceuticals is recalling unexpired lots of Ranitidine Tablets due to potential presence of N-nitrosodimethylamine (NDMA).
FDA sent a warning letter to Dercher Enterprises, Inc., DBA Gordon Laboratories, for CGMP violations and adulterated drug products.
The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.
December 15, 2019
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
Too narrow a focus on regulatory compliance may prevent organizations from embracing-and profiting from-quality and operational excellence.
December 02, 2019
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.