USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA Guidance: Real-Time Oncology Review (RTOR)
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
USFDA: Remote Interactive Evaluations of Drug Manufacturing & Bioresearch Monitoring Facilities
USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices
USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products
USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment
USFDA Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder
USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders
USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products
USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions
USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software
USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program