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Top Industry News
- PDAM Notification of eCTD v4.0 (ICH M8) Information Session on Notification Revision and Start of Operation
- FDA Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
- ANVISA Approves New Regulatory Framework for Registration of New and Innovative Medicines
- MHRA Medical Devices: Guidance for Manufacturers on Vigilance
- ANVISA Publishes Guidelines on Microbiological Control of Cosmetics
- FDA User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications
- MHRA Export Drugs and Medicines: Special Rules
- FDA Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
- MHRA Human Medicines: Register of Electronic Export Certificates
- FDA Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Guidance for Industry