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The FDA replaced its 2001 guidance on organizing electronic common technical documents for submission, updating its recommendations to industry with the ICH’s M4 guideline. Read More
Finger-pointing abounded during a Senate hearing on prescription drug prices, where branded and generic industry representatives testified alongside pharmacy, wholesale distributor and benefit manager groups. Read More
Health Canada proposed fee hikes for reviewing new drug applications, oversight of manufacturing facilities, postmarket monitoring of sales and other regulatory activities. Read More
An EU regulation meant to boost pediatric drug development has led to more medicines for children since it was adopted, although actual use of new products has not increased at the same pace, a European Commission report said. Read More
The European Medicines Agency added new safety information for 15 excipients, including five new ingredients, in its listings of required product labeling. Read More
The European Medicines Agency’s pharmacovigilance committee recommended additional restrictions on Biogen’s Zinbryta (daclizumab), after reviewing its effects on the liver. Read More
The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More
The European Commission formally adopted updated regulations on good manufacturing practices for pharmaceuticals generally and for investigational drugs and clinical trials more specifically. Read More
In a significant policy shift, China plans to accept data from foreign clinical trials in its drug approval process if the drug is already approved overseas. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the launch of its new EudraVigilance drug safety reporting program. Read More