More EDQM updates Guideline on the "Requirements for revision/renewal of CEPs"
More FDA defines Goal Dates for the Processing of Changes in Generics Authorisation Applications
More EMA publishes Document on the Validation of analytical Methods
More European Pharmacopoeia Commission announces Strategy for Implementation of ICH Q3D
More Final ICH M7 Guideline on Genotoxic Impurities published
More Every fifth FDA Warning Letter includes deficiencies regarding Equipment
More Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues
More ICH gets new Members and informs about the ICH Q3D Implementation
More How can a CEP for a starting material be used in a CEP application for an API?
More Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity
More Austrian QP Association (aqpa) publishes Comments on the Annex 15 Draft