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Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher in the U.S. will now pay a $2.7 million fee — a $165,000 increase over fiscal year 2015, which ended Sept. 30. Read More
Despite its lucrative promise, the U.S. Food and Drug Administration’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Delegates from more than 20 countries in Latin America and the Caribbean are calling for comprehensive health and medicines policies and strategies that provide long-term, sustainable and effective solutions for ensuring access to life-saving drugs. Read More
The U.S. Food and Drug Administration is seeking feedback on a draft addendum to the International Conference on Harmonisation’s good clinical practice guideline aimed at streamlining approaches to trial design, conduct, oversight, recording and reporting. Read More
The U.S. Food and Drug Administration has released final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More
The U.S. Food and Drug Administration is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
NHS England will no longer pay for 16 cancer drugs, including products made by Roche, Celgene, Pfizer, Bristol-Myers Squibb, Novartis, Johnson & Johnson and Bayer, after the National Institute for Health and Care Excellence deemed them not cost-effective. Read More
The International Conference on Harmonisation has issued first-ever quantitative guidance on the evaluation and control of mutagenic impurities in medicines to limit potential cancer risk. Read More
The U.S. Food and Drug Administration has banned imports of drugs made at Mumbai, India-based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The European Medicines Agency has released draft guidance explaining how drugmakers can use pharmacodynamic and pharmacokinetic analyses to hasten the development and review of new antibiotics. Read More
European drugmakers are pressing regulators to streamline the conditional marketing authorization pathway for drugs that fulfill unmet needs, saying the current system is slower than the standard authorization process. Read More
Brazil’s Agência Nacional de Vigilância Sanitária is facing criticism from the medical device industry for hiking surveillance inspection fees as the country faces tough economic times. Read More