USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products
USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience
USFDA Guidance: Requests for Reconsideration under GDUFA
USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions
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 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 MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders