January 2, 2018
- Information on Clozapine (updated)
- Patent Certifications and Suitability Petitions (updated)
- FDA-ISoP Public Workshop: Model Informed Drug Development (MIDD) for Oncology Products (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- Generic Drugs Science and Research: Priorities & Projects
- Generic Drugs Science and Research: Research Publications & Resources
- Generic Drugs Science and Research: Guidances & Reports
- Generic Drugs Science and Research: Collaboration Opportunities
- Generic Drugs Science and Research: Generic Drugs Science & Research News
- Drug Trial Snapshot: Ozempic
- Drug Safety Podcasts: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)
- Data Standards Program Action Plan, Version 2.7 (PDF - 229 KB)
- Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry (PDF - 109KB)
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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