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Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
A control laboratory testing facility in Mumbai, India, has come under fire from the FDA after a summer inspection last year raised serious concerns about the quality of drugs tested there. Read More
UK regulators recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 compared to 2012, with the majority of complaints coming from companies complaining about their competitors. Read More
India’s Ministry of Health and Family Welfare on Friday began releasing data about drugmakers’ payouts in cases where clinical trial subjects died during a trial, with the first wave of published data focusing on payouts for trial-related deaths between 2010 and 2013. Read More
Sponsors should use Extensible Markup Language (XML), not Standard Generalized Markup Language (SGML) when transmitting reports about patient reactions in clinical trials, under an FDA final guidance adopted Friday. Read More
In a decision that expands Sovaldi’s market dominance, the European Medicines Agency (EMA) Friday approved compassionate use of the Gilead drug with ledipasvir to treat patients with hepatitis C genotype 1. Read More
Troubled drug compounder and repackager Medisca has landed in hot water with the FDA again after the agency found a different type of drug in recalled lots of L-citrulline. Read More
Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP, after a single glass particle was found in just one vial of a lot of the drug. Read More
Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More