USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
Swiss Medic Guidance: Document on Formal requirements
SFDA Med.Dev: Guidance on National Diagnostic Reference Levels
EC-Med Dev.CG - Guidance on Classification Rules for In-vitro Diagnostic Medical Devices
EMA Checklist: Updated Validation checklist for Type II quality variations
Pakistan DRAP Guidance: GMP for Manufacturing Sites of Drugs
South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products
Ireland's HPRA: Guide to Clinical Trial Applications
Health Canada Guidance: Conduct and Analysis of Comparative Bioavailability Studies
ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
Malaysia MD Guidance: How to Submit an Application for Registration of a Refurbished Medical Device
USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling
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USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions
Australia TGA: FAQ Importing & Supplying Medical Devices
Philippines FDA: Draft Guidance Frontline Services of the FDA in the New Normal
Irelands HPRA's: Guide to Fees for Human Products
USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide