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January 02, 2019
Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.
This year promises to bring more focus on risk management and building a quality culture, says consultant Susan Schniepp.
Understanding the differences in inspection processes is the key to successful global expansion, according to Siegfried Schmitt, PhD, vice-president Technical, PAREXEL Consulting.
Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.
While pharma is proving its capabilities to develop novel therapies, the industry still needs to work on manufacturing innovation.
December 18, 2018
Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.
The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.
Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.
December 13, 2018
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
December 12, 2018
New FDA guidance developed to identify lapses in data integrity and promote best practices.