USFDA: Guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
Saudi's SFDA: Guidance on Regulatory Framework for Drugs Approval
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
TGA Guidance: Regulatory Obligations for Exempt Medical Devices
Swissmedic Guidance: Requesting Product Certificates (CPP)
European Commission: Health Technology Assessment -Guidance on Outcomes for Joint Clinical Assessments and Reporting Requirements
Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
USFDA Guidance: Facility Readiness: Goal Date Decisions Under GDUFA
Swissmedic Guidance: Renewal and Discontinuation of Authorization or Change of Status (Main Authorization/Export License)
USFDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
UK MHRA Guidance: Machine Learning Medical Devices: Transparency Principles
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
EMA Guidance: Procedural Advice on Paediatric Applications
EMA Guidance: IRIS Guide for Applicants