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The FDA highlighted two fictional case studies it published on the role biomarker qualification plays in drug development — as part of a reorganization of the agency’s biomarker materials — to help drugmakers understand the validation studies necessary to support qualification, the collaborative efforts involved and the potential benefits. Read More
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
The European Medicine Agency’s revised guideline on the chemistry of active substances — outlining the information companies must provide the agency about the chemical entities used in a drug product — goes into effect this week. Read More
The China Food and Drug Administration is taking public comments on four proposed reforms, covering the review of new drug applications, the deregulation of clinical trials, postmarket surveillance and intellectual property rights. Read More