USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template
USFDA MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
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 Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program
TGA Guidance: Submitting data in the eCTD format
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
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USFDA Guidance: Premarket Notification [510(k)] Submissions
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
UK MHRA: Guidance on International Recognition Procedure