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The FDA has issued an import alert for an Australian manufacturing plant, barring it from shipping Eli Lilly’s erectile dysfunction drug Cialis into the U.S. Read More
Indian companies that export active pharmaceutical ingredients to the EU can use six months of long-term stability data to show conformity with good manufacturing practices, rather than the previously required 12 months of data. Read More
From now on, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More
The European Medicines Agency on Monday approved Novartis’ Cosentyx as the first front-line biologic for moderate-to-severe plaque psoriasis. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
The UK’s health cost-benefit watchdog is recommending coverage of Janssen’s drug Olysio as a treatment option for people with both genotype 1 and genotype 4 hepatitis C. Read More
Manufacturers that combine drugs with either medical devices or cellular or tissue-based products must determine which category the product falls under before filing a marketing application in Japan, the Pharmaceutical and Medical Devices Agency says. Read More
Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, the U.S. government says. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint authority with Australia. Read More