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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
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More
After fielding nothing but complaints with its proposed generic drug safety labeling rule, the FDA is receiving rare support for the proposal from a coalition of patient groups that says it would give injured consumers a clear avenue for redress. Read More
The FDA plans to tell drugmakers by the end of November how they should exchange data with supply chain partners to satisfy new federal track-and-trace requirements. 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
The FDA Tuesday released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. 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
A congressional committee is reviving an investigation into the FDA’s surveillance of employee emails, and is asking agency officials what the FDA has done to protect whistleblowers from harassment. Read More
Preliminary data from a late-stage trial of Eli Lilly’s type 2 diabetes drug dulaglutide positions the candidate as a major contender in the increasingly competitive drug class known as GLP-1. Read More