October 30, 2017
- Public Notification: Linsen Double Caulis Plus (靈仙双藤素) Contains Hidden Drug Ingredient
- Videos and Podcasts on Regulatory Science at CDER
- Videos and Podcasts on Regulatory Science at CDER: Ashutosh Rao Transcript
- Videos and Podcasts on Regulatory Science at CDER: Amy Rosenberg Transcript
- Videos and Podcasts on Regulatory Science at CDER: Connie Ruzicka Transcript
- Videos and Podcasts on Regulatory Science at CDER: Daniela Verthelyi Transcript
- Videos and Podcasts on Regulatory Science at CDER: Ashutosh Rao Podcast
- Videos and Podcasts on Regulatory Science at CDER: Amy Rosenberg Podcast
- Videos and Podcasts on Regulatory Science at CDER: Connie Ruzicka Podcast
- Videos and Podcasts on Regulatory Science at CDER: Daniela Verthelyi Podcast
- Patent Certifications and Suitability Petitions (updated)
- Generic Drug User Fee Amendments (updated)
- User Fee Lists (updated)
- GDUFA Implementation Quarterly Meetings between FDA and Industry (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials Guidance for Industry (PDF - 222KB)
- Medication Guides Page (Updated)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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