More Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices
More Batch Record Review as GMP Deviation cited in FDA Warning Letters
More EMA adjusts Fees for Marketing Authorisation Applications
More ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components
More Concept Paper on the Revision of the GCP Directive published
More IMPD: EMA provides further Clarification for Quality of IMPs
More Specific WHO Requirements for Dissolution Studies to Support Biowaivers
More Revision or Renewal of CEPs: Requirements for Notifications to the EDQM
More EU-GMP Guide: New Introduction with Clarification of Status of Part III
More "Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper
More New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products
More DMA Document on Expectations for Audits of API Manufacturers
More Updated Q&A Document on the Submission of Variations published