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The European Medicines Agency has issued guidance to help drugmakers improve their responses to scientific objections lodged by EMA review committees. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them, setting up a test case for the EU’s new trial transparency policy. Read More
An FDA advisory committee will meet next month to consider Celltrion’s biosimilar version of Janssen’s Remicade, putting the agency on track to meet a goal of reviewing five biosimilar applications a year. Read More
A proposal to lift restrictions on how drugmakers can promote products on social media and another that would grant up to 15 years of generics-free exclusivity to drugs approved to treat an unmet medical need are emerging as controversial issues in a proposal to overhaul FDA drug approval processes. Read More
In a 46-page draft guidance, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
The FDA is giving industry until March 9 to weigh in again on the controversy surrounding generic first-filer exclusivity determinations and other GDUFA-related issues first raised at a September public hearing. Read More
Long-awaited guidance on designating a biosimilar as interchangeable with the reference product may soon be in the offing, based on an FDA request for comments on a proposed collection of information. Read More