- December 17-18, 2018: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
- Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations
- November 1, 2018: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee Meeting Announcement
- Prescription to Over-the-Counter (OTC) Switch List
- October 24-25, 2018: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
- October 10, 2018: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
- Natural Disaster Preparedness and Response (Drugs)
- La FDA advierte acerca de casos poco frecuentes de una infección grave del área genital con los inhibidores del SGLT2 para la diabetes
- FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
- FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
- FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
- Postmarketing Requirements and Commitments: Reports
- Dermatologic and Ophthalmic Drugs Advisory Committee Roster
- La FDA advierte acerca del incremento del riesgo de reincidencia del cáncer con el uso del antibiótico azitromicina (Zithromax, Zmax) a largo plazo posterior a un trasplante de células madre de donante
- FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files
- Pediatric Exclusivity Granted
- FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
- UPDATED INFORMATION: September 12, 2018: Meeting of the Pharmacy Compounding Advisory Committee Meeting Announcement
- Stay Informed about Small Business
- Inactive Ingredients Database Download
- Drugs@FDA Download File (new structure)
- Newly Added Guidance Documents
- Pediatric Exclusivity Statistics
- FDA Adverse Event Reporting System (FAERS) Public Dashboard
- Oncologic Drugs Advisory Committee Roster
- CDER Key Officials List
- Orange Book Patent Listing Dispute List
- Generic Drug Development
- Additions/Deletions for Prescription and OTC Drug Product Lists
- Orange Book Zip File