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Paris-based AB Science, a developer of tyrosine kinase inhibitors, received an FDA warning letter for failing to report adverse events promptly and lapses in clinical trial monitoring. Read More
A Montana compounder was hit with a 17-observation Form 483 due to issues with its sterile processing, contamination controls and other GMPs. Read More
Nosch Labs, a maker of active pharmaceutical ingredients, was hit with a five-observation FDA Form 483 after workers at its Veliminedu Village, Chityal Madal, India, facility were observed passing off APIs that failed to meet quality control standards. Read More
The FDA has banned all imports from Emcure Pharmaceuticals’ Hinjewadi, Maharashtra, India, facility due to current good manufacturing practice violations, making it the latest in a growing list of Indian firms facing agency action. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
Just as the U.S. Food and Drug Administration is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
The FDA’s Office of Prescription Drug Promotion has warned Herndon, Va., drugmaker ASCEND Therapeutics US for distributing promotional cards about its EstroGel product that omit important risk information. Read More