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Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and that labels be made and applied so that they cannot be damaged by opening a product. Read More
An FDA advisory committee may have given its unanimous approval for a biosimilar application this month, but industry and patient groups contend the regulatory pathway still has many potholes and unanswered questions. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. Read More
The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. 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