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Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued in early March by the Central Drugs Standard Control Organization. Read More
China’s drug approval backlog ballooned to nearly 18,600 applications by the end of 2014, up more than 30 percent from December 2013, with generics applications representing most of the increase. Read More
Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. Read More
Advocacy group Public Citizen is urging the FDA to pull oral forms of the antifungal drug ketoconazole from U.S. shelves due to serious health risks. Read More
The Indian government is planning to relaunch a program that would sell hundreds of quality generic drugs at low cost under its own label, Jan Aushadhi. Read More
The drug pricing authority in India published a compilation of the price caps for 509 drugs, effective this past Jan. 31, to give drugmakers a single source of pricing information. Read More
The European Medicines Agency is establishing a task force to implement common standards for identifying medicines across EU member states, and will require industry and regulators to comply with them beginning in July 2016. Read More
Drugmakers will be able to make major changes to their products faster under a new European Medicines Agency policy of scheduling new variations reviews weekly rather than monthly. Read More