What's New on the FDA Drugs Site
April 21, 2015
- Public Notification: Extreme Diamond 3000 contains hidden drug ingredient
- DDI Webinar- Know Your Source - Protecting Patients from Unsafe Drugs - April 28, 2015
- Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Doxorubicin (Adriamycin) Injection (Updated - Currently in Shortage)
- Methylene Blue Injection (New - Currently in Shortage)
- Nebivolol (BYSTOLIC) Tablets (Updated - Currently in Shortage)
- Trace Elements (Updated - Currently in Shortage)
- Guidance for Industry:
- Clinical Trial Endpoints for the Approval of Non- Small Cell Lung Cancer Drugs and Biologics Guidance for Industry (PDF - 343KB)
- Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry (PDF - 252KB)
- National Drug Code Directory
- Paragraph IV Patent Certifications (updated)
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