July 31, 2019
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves pembrolizumab for advanced esophageal squamous cell cancer.
- FDA approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer.
- Vulvovaginal Candidiasis: Developing Drugs for Treatment Guidance for Industry
- Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry
- General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
- E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES
- Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry
- Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers
- National Drug Code Directory (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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