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The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
Just days before Sandoz launched Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the U.S. Food and Drug Administration issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
GlaxoSmithKline, which last year paid Chinese authorities $483 million to settle corruption charges, is facing similar allegations in Romania. Read More
The Indian government is considering establishing a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by giving drugmakers targeted advice on postmarket study design. Read More
The U.S. Food and Drug Administration and European Medicines Agency will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. Read More