Titles
- Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization1
- Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)1
- Eosinophilic esophagitis: developing drugs for treatment1
- Expiration dating of unit-dose repackaged solid oral dosage form drug products1
- Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing1
- Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment1
- Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment1
- Human gene therapy for hemophilia1
- Human gene therapy for rare diseases1
- Human gene therapy for retinal disorders1
- Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act1
- In vitro drug interaction studies: cytochrome P-450 enzyme- and transporter-mediated drug interactions1
- Institutional review board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency: guidance for IRBs and clinical investigators1
- Limited population pathway for antibacterial and antifungal drugs1
- Long term follow-up after administration of human gene therapy products1
- Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format1
- Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff1
- Notifying FDA of a permanent discontinuance or interruption in manufacturing under section 506C of the FD&C Act1
- Opioid use disorder: endpoints for demonstrating effectiveness of drugs for treatment1
- Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval1