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The European Medicines Agency is planning to revise its guideline on the role of pharmacokinetics in pediatric drug development and is inviting public comment. Read More
For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More
Drugmakers are increasingly using joint ventures and research consortia to accelerate early stages of drug development and share the burden of cost, according to Deloitte. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The European Medicines Agency published a draft proposal to accept measurements of fibrinogen as a biomarker to identify chronic obstructive pulmonary disease patients for inclusion in clinical trials. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More