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The European Medicines Agency revised its 2009 guideline on developing treatments for axial spondyloarthritis, accounting for changes in clinical practice. Read More
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in previously untreated patients. Read More
The European Medicines Agency published a new draft guideline on developing medicines and vaccines against respiratory syncytial virus infections, including monoclonal antibodies and direct-acting antivirals. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. 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 FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More