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The FDA has updated its list of planned guidances for the calendar year to include one on evaluating the abuse-deterrent properties of generic solid oral opioid drugs. Read More
The South Carolina Supreme Court more than halved the $327 million in penalties imposed on Johnson & Johnson’s Janssen drug unit by a lower court for hiding the risks of its drug Risperdal, ruling that the penalties levied on the company were excessive. Read More
The FDA has postponed an advisory committee meeting that had been scheduled to consider Celltrion’s application for a biosimilar to Janssen’s Remicade – just the second advisory committee meeting to consider a biosimilar application in the U.S. Read More
India regulators barred two drugmakers from doing business in the country for five years for submitting false information in new drug applications. 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 FDA has laid out a regulatory research agenda for the year that includes identifying better methods for assessing generics, improving drug safety, biosimilars development and finding ways to assess advanced, new drugs as areas where the agency would like to sponsor research. Read More
Mexican regulators laid out rules for older biosimilars registered prior to Oct. 19, 2011, when the country’s biosimilarity rules were first established, mandating that companies conduct clinical trials to prove biosimilarity. Read More