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The European Medicines Agency has extended its pilot program for coordinating international generic drug applications. Under the pilot, drugmakers can make joint submissions through the EU’s centralized procedure and the regulatory authorities of Australia, Canada, Taiwan and Switzerland. 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
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
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
In a preview of how the U.S. Food and Drug Administration’s new Office of Pharmaceutical Quality will speed generic drug approvals, the office is rolling out a framework for filers of abbreviated new drug applications to respond to minor queries regarding chemistry, manufacturing and control early in the review cycle. Read More
An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides. Read More