Swissmedic Guidance: Product Information for Human Medicinal Products
Ireland's HPRA: Guide to Labels and Leaflets of Human Medicines
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
TGA MD Guidance: Medical Device Labelling Obligations
USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area
USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
USFDA Statement: New Patient Medication Information - Medication Guide for Patients
Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
Malaysiaās MDA: Med Dev Guidance on Requirement for Labeling & Change Notification of Registered MD
Japan PMDA: Guidelines for Labeling of Codes on Containers to Identify Prescription Drugs & Med. Dev
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
USFDA Guidance: Content & Format of Labeling for Non-Prescription Drugs, Quantitative Labeling
USFDA: Revising the National Drug Code Format and Drug Label Barcode Requirements