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PhRMA placed itself in the middle of a mounting battle over biosimilar naming Monday, calling on the FDA to deny GPhA’s petition for same-name biosimilars and arguing that distinguishable, yet related names are “essential” for adverse event reporting. Read More
Beginning in June, drugmakers selling in the EU must notify the European Medicines Agency (EMA) of any unreported changes or updates to product marketing authorizations in any member states and must complete that update on all products by December. Read More
Pharma companies applying for approval to sell drugs in Canada must submit quality summary documents, certifications of their products’ comparability with monographs of the European Pharmacopoeia and detailed drug master files that comply with the International Conference on Harmonisation’s (ICH) registration for human use quality standards. Read More
With only 14 compounding facilities having volunteered for FDA oversight in two months, the agency is now asking hospitals and state authorities to get behind the registration effort. Read More
The FDA wants IND sponsors to stop the practice of routinely using age limits as exclusion criteria for clinical trials and increase the number of patients with multiple chronic conditions included in drug studies. Read More
The FDA on Feb. 1 will begin sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More
After a tough 2013, Teva received some good news Tuesday in the form of a newly approved formulation of its blockbuster drug Copaxone, helping the product gain new market share as Teva fights off generic competition. Read More