USFDA Guidance: Requests for Reconsideration under GDUFA
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
USFDA : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy Products
USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products
USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data
USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices
USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports
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