Top Industry News
- FDA Issues Draft Guidance to Industry on Submitting Real-World Evidence in New Drug and Biologic Applications
- FDA- Determining Whether to Submit an ANDA or a 505(b)(2) Application
- Chinese Center for Drug Evaluation (CDE)- Notice about Submitting the CD-ROM of the Declaration form for Drug Registration Inspection
- HPRA- Guide for National Scientific and Regulatory Advice
- FDA Finalizes Recommendations for Studying Absorption of Active Ingredients in Topically-Applied OTC Monograph Drugs
- MEB- Amended Policy Relating to Patented Indications
- ANVISA- Updated Planning of Regulatory Agenda topics
- Swissmedic- Adaptation of the Guidance Document Orphan Drug HMV4
- FDA- Interchangeable Biosimilars: FDA Finalizes Guidance
- FDA Issues Guidance on Food Contact Substances for Use with Infant Formula and/or Human Milk
- ICH Drafts Revised Guideline on General Considerations for Clinical Studies
- FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards